XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
Applicant
Stryker Corporation
Product Code
NKB · Orthopedic
Decision Date
Dec 2, 2015
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral 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, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 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.
Device Story
XIA® 4.5 Spinal Fixation System consists of monoaxial/polyaxial bone screws, hooks, staples, blockers, rods, and connectors for spinal stabilization. New components include cannulated/non-cannulated polyaxial screws (diameters 4.0-9.5mm) and transition rods. Power Adaptor Instrument Accessory facilitates pedicle screw insertion using powered drivers (Stryker CD3 Cordless Driver 3, RemB Universal Driver) via Hudson Modified Trinkle Reamer interface. Used in OR by surgeons to provide spinal immobilization/stabilization. Power adaptors act as mechanical interface between power drivers and screwdrivers. System enables manual or powered screw insertion. Benefits include rigid fixation to support fusion in degenerative, traumatic, or deformity-related spinal conditions.
Clinical Evidence
Bench testing only. Mechanical testing performed per ASTM F1717-14 (static compression, static torsion, dynamic compression bending), ASTM F2193-14/F543-13 (axial pull-out), and ASTM F1798-13 (flexion-extension, axial gripping, axial torque gripping). Cadaveric validation study performed for power screw insertion.
Technological Characteristics
System components include polyaxial/monoaxial screws, rods, and connectors. Materials are established, well-known spinal implant materials. Mechanical interface via Hudson Modified Trinkle Reamer for power-assisted insertion. No changes to power adaptor accessory. Testing complies with FDA Guidance for Spinal System 510(k) (May 3, 2004).
Indications for Use
Indicated for skeletally mature and pediatric patients requiring non-cervical spinal fixation (pedicle/non-pedicle) for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, and failed fusion. Pediatric use limited to posterior approach for progressive deformities and specific pathologies. Used as adjunct to fusion with autograft/allograft.
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 Spine Power Adaptor Instrument Accessory (K120434)
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a human face in profile, with three overlapping faces suggesting community and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2015
Stryker Corporation Ms. Sorava King Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K152632 Trade/Device Name: XIA® 4.5 Spinal Fixation System, Power Adaptor Instrument Accessory 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: September 14, 2015 Received: September 16, 2015
Dear Ms. King:
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 Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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.
## Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------|-----------------------------------------|
| Expiration Date: January 31, 2017 | Food and Drug Administration |
| See PRA Statement below. | <b>Indications for Use</b> |
| 510(k) Number (if known) | K152632 |
|--------------------------------|---------------------------------|
| Device Name | XIA® 4.5 Spinal Fixation System |
| Indications for Use (Describe) | |
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral 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, neuromuscular scoliosis, and congenital scoliosis. Additionally, the
XIA® 4.5 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) | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|----------------------|-------------|
|----------------------|-------------|
PSC Publishing Services (301) 443-6740 EF
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
| <b>Indications for Use</b> |
| Form Approved: OMB No. | 0910-0120 |
|------------------------|--------------------------|
| Expiration Date: | January 31, 2017 |
| | See PRA Statement below. |
| 510(k) Number (if known) | K152632 |
|--------------------------|------------------------------------|
| Device Name | Power Adaptor Instrument Accessory |
| Indications for Use (Describe) |
|--------------------------------|
| Intended Use (Power): |
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker
Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the
Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power
adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to
rotate screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered
(corded and cordless) instrumentation. The systems included are the family of XIA® Spinal Systems (XIA® Stainless
Steel, XIA® II, XIA® Anterior, and XIA® Precision), XIA® 3 Spinal System, XIA® 4.5 Spinal System, Radius® Spinal
System, MANTIS® Spinal System, MANTIS® Redux Spinal System, and the ES2® Spinal System.
| Indications for Use (Power): |
|------------------------------|
|------------------------------|
The XIA® Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle
fixation in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc disease
(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic
studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvature (i.e. scoliosis, kyphosis, and/or
lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The XIA® 3, RADIUS® Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/
anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the XIA® II, XIA® 3, and RADIUS®
Spinal Systems are intended to provide additional support during fusion using autograft or allograft in skeletally mature
patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD)
(defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
tumor; pseudoarthrosis; and failed previous fusion.
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; pseudoarthrosis; 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, neuromuscular scoliosis, and congenital scoliosis. Additionally, the
XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture
caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with
| FORM FDA 3881 (8/14) | Page 1 of 2 |
|----------------------------------------|-------------|
| PSC Publishing Services (301) 443-6740 | EF |
{4}------------------------------------------------
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| XIA® 4.5 Spinal Fixation System | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Stryker Corporation<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
| Contact Person | Soraya King<br>Regulatory Affairs Project Manager<br>Phone: 201-749-8296<br>Email: Soraya.King@stryker.com |
| Date | November 23, 2015 |
| Trade Name | 1. XIA® 4.5 Spinal Fixation System<br>2. Power Adaptor Instrument Accessory |
| Proposed Class | Class III |
| Classification Name<br>and Number | Pedicle Screw Spinal System, 21 CFR 888.3070 |
| Product Code | NKB, OSH, MNH, MNI, KWP, KWQ |
| Predicate Devices | 1. The XIA® 4.5 Spinal Fixation Systems was shown to be<br>substantially equivalent to the devices listed below:<br>Primary<br>Predicate<br>Stryker Spine XIA® 4.5 Spinal System, K142381 Additional<br>Predicates Stryker Spine XIA® 4.5 Spinal System (K140276, K133188, K121342, K060361) Medtronic CD Legacy (Horizon), K020709 DePuy Motech Moss Miami, K950697 Stryker Spine RADIUS® Spinal System, K101144 Stryker Spine XIA® 3 Spinal System, K142381 |
| | 2. The Stryker Spine Power Adaptor Instrument Accessory<br>was shown to be substantially equivalent to the device listed<br>below:<br>Additional Predicate Stryker Spine Power Adaptor Instrument Accessory, K120434 |
| Device Description | 1. The XIA® 4.5 Spinal System is comprised of monoaxial and<br>polyaxial bone and reduction screws, hooks, dual staples, and<br>blockers that affix rods, rod-to-rod connectors, growth<br>connectors, and cross connectors to vertebrae of the spinal<br>column. This submission will introduce new cannulated and |
| XIA® 4.5 Spinal Fixation System | |
| non-cannulated polyaxial screws, dual lead self-tapping<br>cortical thread screws, a blocker, top loading rod-to-rod<br>connectors, angled side/top loading connectors, and<br>transition rods. | |
| The new XIA® 4.5 components consist of additional polyaxial<br>diameter screws (Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø 6.5, Ø8.5 and<br>Ø9.5) in cannulated and non-cannulated designs in various<br>lengths (20mm – 100mm), a blocker, and a new transition rod.<br>The newcomponents will be used in the same manner as the<br>existing predicate XIA® 4.5 Spinal System. | |
| 2. The XIA® 4.5 Spinal System will continue to be used<br>with the Stryker Spine Power Adaptor Accessory<br>Instrument, Stryker Instruments Hudson Modified Trinkle<br>Reamer, the CD3 Cordless Driver 3 System, and the RemB<br>Universal Driver, to facilitate the insertion of the pedicle<br>screws. The adaptors serve as a mechanical interface<br>between the power drivers and screwdriver instruments.<br>When the adaptor is attached to the Hudson Modified<br>Trinkle Reamer, the RemB Corded driver or the CD3<br>Cordless Driver 3 provides appropriate power to rotate the<br>screw drivers for the insertion of the pedicle screws. The<br>accessory indications for use were updated to reflect the<br>indications for use of the XIA® 4.5 Spinal System. | |
| Intended Use and<br>Indications for Use<br>for the XIA® 4.5<br>Spinal System | |
| | The XIA® 4.5 Spinal System is intended for<br>anterior/anteriolateral and posterior, non-cervical pedicle and<br>non-pedicle fixation for the following indications: |
| | Degenerative Disc Disease (as defined by back pain of<br>discogenic origin with degeneration of the disc confirmed<br>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<br>System, and XIA® 4.5 Spinal System can be linked to the XIA®<br>4.5 Spinal System via the rod-to-rod connector when used for<br>the aforementioned indications in skeletally mature patients as<br>an adjunct to fusion. |
| XIA® 4.5 Spinal Fixation System | |
| | Except for the staples, when used for posterior non-cervical<br>pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal<br>System implants are indicated as an adjunct to fusion to treat<br>progressive spinal deformities (i.e. scoliosis, kyphosis, or<br>lordosis) including idiopathic scoliosis, neuromuscular<br>scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5<br>Spinal System is intended to treat pediatric patients diagnosed<br>with: spondylolisthesis/spondylolysis, fracture caused by tumor<br>and/or trauma, pseudarthrosis, and/or failed previous fusion.<br>This system is intended to be used with autograft and/or<br>allograft. Pediatric pedicle screw fixation is limited to a<br>posterior approach. |
| Indications &<br>Intended Use with<br>Power Adaptor<br>Instrument<br>Accessory | Intended Use:<br>To facilitate the placement of pedicle screws using the power<br>technique (corded and cordless), the use of the Stryker Spine<br>Power Adaptor is intended for exclusive use with the Stryker<br>Instruments Hudson Modified Trinkle Reamer and the Stryker<br>Instruments CD3 Cordless Driver 3 and the Stryker<br>Instruments RemB Universal Driver. When the power<br>adaptors are attached, the CD3 Cordless Driver 3 and RemB<br>Universal Driver provide power (corded and cordless) to rotate<br>screwdrivers for the insertion of pedicle screws.<br><br>Pedicle screws from select Stryker Spine implant systems<br>may be implanted in the non-cervical spine using powered<br>(corded and cordless) instrumentation. The systems included<br>are the family of XIA® Spinal Systems (XIA® Stainless Steel,<br>XIA® II, XIA® Anterior, and XIA® Precision), XIA® 3 Spinal<br>System, XIA® 4.5 Spinal System, Radius® Spinal System,<br>MANTIS® Spinal System, MANTIS® Redux Spinal System,<br>and the ES2® Spinal System. |
| | Indications for Use:<br>The XIA® Spinal System is intended for<br>anterior/anteriolateral and posterior, non-cervical pedicle<br>and non-pedicle fixation in skeletally mature patients as an<br>adjunct to fusion for the following indications: Degenerative<br>Disc disease (DDD) (defined as back pain of discogenic<br>origin with degeneration of the disc confirmed by history<br>and radiographic studies); spondylolisthesis; trauma (i.e.<br>fracture or dislocation); spinal stenosis; curvature (i.e.<br>scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis;<br>and failed previous fusion. |
| XIA® 4.5 Spinal Fixation System | |
| The XIA® 3, RADIUS® Spinal Systems are intended for use in<br>the non-cervical spine. When used as an<br>anterior/anteriolateral and posterior, non-cervical pedicle and<br>non-pedicle fixation system, the XIA® II, XIA® 3, and<br>RADIUS® Spinal Systems are intended to provide additional<br>support during fusion using autograft or allograft in skeletally<br>mature patients in the treatment of the following acute and<br>chronic instabilities or deformities: degenerative disc disease<br>(DDD) (defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and<br>radiographic studies); spondylolisthesis; trauma (i.e. fracture<br>or dislocation); spinal stenosis; curvatures (i.e. scoliosis,<br>kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed<br>previous fusion. | |
| The XIA® 4.5 Spinal System is intended for<br>anterior/anterolateral and posterior, non-cervical pedicle and<br>non-pedicle fixation for the following indications:<br>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); spinal stenosis;<br>curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor;<br>pseudarthrosis; failed previous fusion. | |
| The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal<br>System, and XIA® 4.5 Spinal System can be linked to the<br>XIA® 4.5 Spinal System via the rod-to-rod connector when used<br>for the aforementioned indications in skeletally mature patients<br>as an adjunct to fusion. | |
| Except for the staples, when used for posterior non-cervical<br>pedicle screw fixation in pediatric patients, the XIA® 4.5<br>Spinal System implants are indicated as an adjunct to fusion to<br>treat progressive spinal deformities (i.e. scoliosis, kyphosis, or<br>lordosis) including idiopathic scoliosis, neuromuscular<br>scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5<br>Spinal System is intended to treat pediatric patients diagnosed<br>with: spondylolisthesis/spondylolysis, fracture caused by<br>tumor and/or trauma, pseudarthrosis, and/or failed previous<br>fusion. This system is intended to be used with autograft<br>and/or allograft. Pediatric pedicle screw fixation is limited to a<br>posterior approach. |…
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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.
