Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
Applicant
Zimmer Biomet Spine, Inc.
Product Code
NKB · Orthopedic
Decision Date
Sep 27, 2017
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft. In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach. Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use. In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use.
Device Story
System comprises spinal rods, pedicle screws, hooks, and connectors for temporary stabilization during spinal fusion; includes Vitality®+ Power instruments (drills, taps, drivers, adapters) for use with Zimmer Biomet Universal Power System. Implants constructed from medical grade titanium alloy or cobalt chromium; single-use only. Used in OR by surgeons for open or minimally invasive spinal procedures. Power instruments facilitate pedicle/ilium preparation and screw insertion. System allows customized constructs; compatible with Instinct® Java™, APEX®, and Universal Clamp® systems. Output is a rigid spinal construct supporting bone graft fusion; removed after solid fusion. Benefits include surgical correction of spinal conditions and stabilization.
Clinical Evidence
No clinical trials performed. Evidence consists of cadaveric testing and clinical literature assessment to demonstrate substantial equivalence to predicate systems.
Technological Characteristics
Implants: medical grade titanium alloy or cobalt chromium. Instruments: reusable drills, taps, drivers, adapters for electric handpiece. Connectivity: mechanical integration with Zimmer Biomet Universal Power System. Sterilization: not specified. Design: thoracolumbar/sacroiliac fixation system.
Indications for Use
Indicated for skeletally mature and adolescent patients requiring non-cervical spinal fixation (T1-S2/ilium). Used as adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, deformities (scoliosis, kyphosis, lordosis, Scheuermann's), tumor, stenosis, pseudoarthrosis, and failed fusion. Specific indication for severe spondylolisthesis (Grade 3-4) at L5-S1. Pediatric use limited to posterior approach for adolescent idiopathic scoliosis.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632)
Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2017
Zimmer Biomet Spine, Inc. Ms. Kelly Stratton Regulatory Affairs Specialist 10225 Westmoor Drive Westminster, Colorado 80021
Re: K172275
Trade/Device Name: Vitality® Spinal Fixation System, Vitality®+ Power Instrument System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: July 27, 2017 Received: July 28, 2017
Dear Ms. Stratton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Ronald P. Jean - S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
#### K172275
Device Name Vitality® Spinal Fixation System
#### Indications for Use (Describe)
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scolosis, Scheuermann's Disease), tumor, stenoss, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusionenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct Java® System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.
In order to achieve additional levels of fixation the Vitality® Spinal Fixation System rods may be connected to the Instinct Java® System (05.5mm rod) or the Virage® OCT Spinal Fixation System (03.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct Java® System and Virage® OCT Spinal Fixation System package inserts for instructions for use.
# Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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# Indications for Use
510(k) Number (if known)
## K172275
Device Name Vitality®+ Power Instrument System
#### Indications for Use (Describe)
#### Intended Use (Power):
Vitality®+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws using a power surgical technique. Pedicle and iliac screws from the Vitality® Spinal Fixation System may be implanted in the non-cervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.
#### Indications for Use (Power):
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scolosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fitality® Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusione graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. The Vitality® System is intended to be used with autograft and or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.
Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct Java® System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.
In order to achieve additional levels of fixation the Vitality® Spinal Fixation System rods may be connected to the Instinct Java® System (05.5mm rod) or the Virage® OCT Spinal Fixation System (03.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct Java® System and Virage® OCT Spinal Fixation System package inserts for instructions for use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/6/Picture/0 description: The image shows the Zimmer Biomet logo, which includes a stylized blue "Z" inside a circle, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. Below the company name, the text "K172275" is displayed, followed by "Page 1 of 5". This suggests that the image is part of a document or report, possibly related to a medical device or procedure.
# 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date | September 13, 2017 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor | Zimmer Biomet Spine, Inc.<br>10225 Westmoor Dr.<br>Westminster, CO 80021 |
| Contact Person | Kelly Stratton<br>Regulatory Affairs Specialist<br>Phone: 303-501-8386<br>Fax: 303-501-8444 |
| Trade Name | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System |
| Common Name | Pedicle Screw Spinal System |
| Device Class | Class II |
| Classification Name | Thoracolumbosacral Pedicle Screw System (NKB)<br>Class II per 21 CFR §888.3070<br>Appliance, Fixation, Spinal Interlaminal (KWP)<br>Class II per 21 CFR §888.3050<br>Appliance, Fixation, Spinal Intervertebral Body (KWQ)<br>Class II per 21 CFR §888.3060 |
| Device Panel | Orthopedic |
# Device Description & Technological Characteristics:
# 1. Vitality® Spinal Fixation System
The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.
The system also includes instrumentation for insertion and removal and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical
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Image /page/7/Picture/0 description: The image shows the Zimmer Biomet logo, which includes a stylized blue "Z" inside a circle, followed by the text "ZIMMER BIOMET" in gray. Below the logo and text, the text "K172275" is displayed, followed by "Page 2 of 5". The text is in a smaller font size than the company name.
grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.
The Vitality® Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java "Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.
#### 2. Vitality®+ Power Instrument System
The Vitality®+ Power Instrument System includes instrumentation to be used with power for the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws. The system includes reusable Vitality drills, taps, drivers and adapters to be used with an electric handpiece. The subject instruments are compatible for use with the Vitality® Spinal Fixation System implants.
The proposed instruments subject of this submission are intended for exclusive use with Zimmer Biomet Universal Power System.
## Intended Use/ Indications for Use
## 1. Vitality® Spinal Fixation System
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The Vitality® System is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.
Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp®
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Image /page/8/Picture/0 description: The image shows the Zimmer Biomet logo, along with the text "K172275 Page 3 of 5". The logo consists of a blue circle with a stylized "Z" inside, followed by the company name in gray. The text below the logo indicates a document identifier and page number.
(titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.
In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use.
# 2. Vitality®+ Power Instrument System
## Intended Use (Power):
Vitality®+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality Spinal Fixation System screws using a power surgical technique.
Pedicle and iliac screws from the Vitality® Spinal Fixation System may be implanted in the noncervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.
# Indications for Use (Power):
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are 13sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The
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Image /page/9/Picture/0 description: The image shows the Zimmer Biomet logo, with the text "ZIMMER BIOMET" in gray. Below the logo, the text "K172275" and "Page 4 of 5" are printed in a smaller font size. The logo consists of a stylized letter Z inside a circle.
Vitality® System is intended to be used with autograft. Pediatric pediale screw fixation is limited to a posterior approach.
Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.
In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use.
## Summary of Technological Characteristics:
## 1. Vitality® Spinal Fixation System
The technological characteristics of the subject Vitality® Spinal Fixation System remain the same as, or similar to, the predicate Vitality® Spinal Fixation System (K171907) in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, materials, and operational principles.
## 2. Vitality®+ Power Instrument System
The subject Vitality®+ Power Spinal Fixation System includes instrumentation to be used with power for the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws. The subject system has the same technological characteristics as predicates Vitality® Spinal Fixation System (K171907), Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632), and Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679) in terms of design, fundamental technology, materials and manufacturing methods. The performance characteristics and operational principles are substantially equivalent.
# Summary of Non-Clinical Testing / Performance Data:
Nonclinical testing was performed to demonstrate that the subject Vitality® Spinal Fixation System with Vitality®+ Power instruments is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Cadaveric Testing .
- Clinical Literature Assessment
# Predicates:
Primary Predicate: Vitality® Spinal Fixation System (K171907) Additional Predicates:
> Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632)
Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679)
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Image /page/10/Picture/0 description: The image shows the Zimmer Biomet logo, which includes a stylized letter Z inside a circle. Below the logo are the alphanumeric characters "K172275" and the text "Page 5 of 5". The text likely indicates a document identifier and page number within a larger document.
# Substantial Equivalence:
The results from the non-clinical testing and analysis show that the subject Vitality® Spinal Fixation System is substantially equivalent to the Vitality® Spinal Fixation System (K171907), Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632), and Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679).
## Conclusion:
The Vitality® Spinal Fixation System is substantially equivalent to the predicate system as a spinal fixation device in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, cadaveric testing and clinical literature assessment sufficiently demonstrate the substantial equivalence of the subject components to the Vitality® Spinal Fixation System, which has been cleared for non-cervical spinal fixation. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
