The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: • Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - · Spondylolisthesis - · Trauma (i.e. fracture of dislocation) - · Spinal stenosis - · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudarthrosis - · Failed previous fusion The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: · Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - · Spondylolisthesis - · Trauma (i.e. fracture of dislocation) - · Spinal stenosis - · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudarthrosis - · Failed previous fusion The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis. kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Device Story
Xia® 3 and Xia® 4.5 Spinal Systems are mechanical spinal fixation implants; comprised of screws, hooks, rods, blockers, and connectors. Used by surgeons in clinical settings to stabilize or correct spinal column segments. Implants affix to vertebrae to provide support during fusion procedures. Systems utilize autograft/allograft to facilitate bone fusion. Devices are intended for non-cervical spine applications; pediatric use restricted to posterior approach. No electronic or software components involved.
Clinical Evidence
No clinical data; bench testing only. Submission relies on substantial equivalence to predicate devices through expansion of indications.
Technological Characteristics
Mechanical spinal fixation system. Components include monoaxial/polyaxial bone screws, reduction screws, hooks, dual staples, blockers, rods, and connectors. Materials, geometries, and fundamental technologies are identical to predicate devices. No energy source or software.
Indications for Use
Indicated for skeletally mature and pediatric patients requiring non-cervical spinal fixation as an adjunct to fusion. Treats degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, and failed previous fusion. Pediatric use limited to posterior pedicle screw fixation for progressive deformities and specified conditions.
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.
Predicate Devices
Medtronic Sofamor Danek, CD HORIZON® Spinal System (K140276)
Stryker Spine Xia® 3 Spinal System (K113666, 133188)
Stryker Spine Xia® 4.5 Spinal System (K121342, 133188)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing right, with flowing lines extending from the heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2014
Stryker Spine Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K142381 Trade/Device Name: Xia® 3 and Xia® 4.5 Spinal Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ Dated: August 25, 2014 Received: August 28, 2014
Dear Dr. Hayeck:
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 vour 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 Part 807); labeling (21 CFR Part 801); medical device 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.
{1}------------------------------------------------
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 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 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 yours,
# Ronald#Alean -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) K142381
Device Name Xia® 3 Spinal System
#### Indications for Use (Describe)
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e. fracture of dislocation)
- · Spinal stenosis
- · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
2 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:
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{4}------------------------------------------------
## Indications for Use
510(k) Number (if known) K142381
Device Name Xia® 4.5 Spinal System
Indications for Use (Describe)
The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
· Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e. fracture of dislocation)
- · Spinal stenosis
- · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion
The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis. kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
2 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)
{5}------------------------------------------------
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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| 510(k) Summary: Xia® 3 and Xia® 4.5 Spinal Systems | |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401 |
| Contact Person | Garry T. Hayeck, Ph.D.<br>Senior Regulatory Affairs Specialist<br>Phone: 201-760-8043<br>Fax: 201-760-8406<br>E-mail: garry.hayeck@stryker.com |
| Date Prepared | October 2, 2014 |
| Trade Names | 1. Xia® 3 Spinal System<br><br>2. Xia® 4.5 Spinal System |
| Common Name | 1. Xia® 3 Spinal System<br>Spinal Fixation Appliances<br><br>2. Xia® 4.5 Spinal System<br>Spinal Fixation Appliances |
| Proposed Class | 1. Xia® 3 Spinal System<br>Class III<br><br>2. Xia® 4.5 Spinal System<br>Class III |
| Classification Name,<br>Codification | 1. Xia® 3 Spinal System Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 Pedicle Screw Spinal System, 21 CFR § 888.3070 (b) (1) & (b) (2) 2. Xia® 4.5 Spinal System Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 Pedicle Screw Spinal System, 21 CFR § 888.3070 (b) (1) & (b) (2) |
| Product Codes | 1. Xia® 3 Spinal System<br>OSH, NKB, KWP, KWQ, MNH, MNI<br><br>2. Xia® 4.5 Spinal System<br>OSH, NKB, KWP, KWQ, MNH, MNI |
| Predicate Devices | 1. Xia® 3 Spinal System Primary Predicate: Medtronic Sofamor Danek, CD HORIZON®<br>Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 3 Spinal System: K113666,<br>133188 2. Xia® 4.5 Spinal System Primary Predicate: Medtronic Sofamor Danek, CD HORIZON®<br>Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 4.5 Spinal System:<br>K121342, 133188 |
| Device Description | 1. Xia® 3 Spinal System<br>The Xia® 3 Spinal System is comprised of screws, blockers, and |
| | hooks that affix rods and connectors to vertebrae of the spinal<br>column for purposes of stabilization, or corrective action through<br>the application of force. |
| | 2. Xia® 4.5 Spinal System<br>The Xia® 4.5 Spinal System is comprised of monoaxial and polyaxial<br>bone and reduction screws, hooks, dual staples, and blockers that<br>affix rods, rod-to-rod connectors, and cross connectors to<br>vertebrae of the spinal column. |
| Indications for Use | 1. Xia® 3 Spinal System<br>The Xia® 3 Spinal System is intended for use in the non-cervical<br>spine. When used as an anterior/anterolateral and posterior, non-<br>cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal<br>System is intended to provide additional support during fusion using<br>autograft or allograft in skeletally mature patients in the treatment<br>of the following acute and chronic instabilities or deformities: |
| | • Degenerative Disc Disease (as defined by back pain of<br>discogenic origin with degeneration of the disc confirmed by<br>patient history and radiographic studies)<br>• Spondylolisthesis<br>• Trauma (i.e. fracture of dislocation)<br>• Spinal stenosis<br>• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)<br>• Tumor<br>• Pseudarthrosis<br>• Failed previous fusion |
| | The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and<br>6.0 mm Vitallium rods from the Xia® Spinal System are intended to<br>be used with the other components of the Xia® 3 Spinal System. |
| | When used for posterior, non-cervical, pedicle screw fixation in<br>pediatric patients, the Xia® 3 Spinal System implants are indicated<br>as an adjunct to fusion to treat progressive spinal deformities (i.e.,<br>scoliosis, kyphosis, or lordosis) including idiopathic scoliosis,<br>neuromuscular scoliosis, and congenital scoliosis. Additionally, the<br>Xia® 3 Spinal System is intended to treat pediatric patients<br>diagnosed with: spondylolisthesis/spondylolysis, fracture caused by<br>tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.<br>This system is intended to be used with autograft and/or allograft.<br>Pediatric pedicle screw fixation is limited to a posterior approach. |
| | 2. Xia® 4.5 Spinal System<br>The Xia® 4.5 Spinal System is intended for anterior/anterolateral<br>and posterior, non-cervical pedicle and non-pedicle fixation for<br>the following indications: |
| | • Degenerative Disc Disease (as defined by back pain of<br>discogenic origin with degeneration of the disc confirmed by<br>patient history and radiographic studies) |
| | • Spondylolisthesis<br>• Trauma (i.e. fracture of dislocation)<br>• Spinal stenosis<br>• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)<br>• Tumor<br>• Pseudarthrosis<br>• Failed previous fusion<br>The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System,<br>and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal<br>System via the rod-to-rod connector when used for the<br>aforementioned indications in skeletally mature patients as an<br>adjunct to fusion.<br>Except for the staples, when used for posterior non-cervical pedicle<br>screw fixation in pediatric patients, the Xia® 4.5 Spinal System<br>implants are indicated as an adjunct to fusion to treat progressive<br>spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including<br>idiopathic scoliosis, neuromuscular scoliosis, and congenital<br>scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to<br>treat pediatric patients diagnosed with:<br>spondylolisthesis/spondylolysis, fracture caused by tumor and/or<br>trauma, pseudarthrosis, and/or failed previous fusion. This system is<br>to be used with autograft and/or allograft. Pediatric pedicle screw<br>fixation is limited to a posterior approach. |
| Summary of<br>Technological<br>Characteristics | 1. Xia® 3 Spinal System<br>The subject Xia® 3 Spinal System shares the same materials,<br>geometries, and fundamental scientific technologies as the<br>predicate Xia® 3 Spinal System. None of the aforementioned<br>characteristics have been altered, augmented, or otherwise<br>changed. |
| | 2. Xia® 4.5 Spinal System<br>The subject Xia® 4.5 Spinal System shares the same materials,<br>geometries, and fundamental scientific technologies as the<br>predicate Xia® 4.5 Spinal System. None of the aforementioned<br>characteristics have been altered, augmented, or otherwise<br>changed. |
| Summary of<br>Performance Data | This submission seeks to build upon predicate Xia® 3 and Xia® 4.5<br>Spinal Systems through expansion of indications only. Therefore, no<br>additional performance data is necessary. |
| Conclusion | 1. Xia® 3 Spinal System<br>The devices of the subject Xia® 3 Spinal System are equivalent in<br>materials, geometries, and intended use to the previously cleared<br>Xia® 3 Spinal System and CD Horizon System. The expanded<br>indications of the Xia® 3 Spinal System are identical to the<br>indications of the predicate CD Horizon System. We therefore<br>conclude that the subject Xia® 3 Spinal System is substantially<br>equivalent to the identified predicate systems. |
| | The devices of the subject Xia® 4.5 Spinal System are equivalent in<br>materials, geometries, and intended use to the previously cleared<br>Xia® 4.5 Spinal System and CD Horizon System. The expanded<br>indications of the Xia® 4.5 Spinal System are identical to the<br>indications of the predicate CD Horizon System. We therefore<br>conclude that the subject Xia® 4.5 Spinal System is substantially<br>equivalent to the identified predicate systems. |
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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.
