The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis

The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Pseudoarthrosis;
• Spondylolysis:
• Spondylolisthesis;
• Spinal stenosis;
• Tumors:
• Trauma (i.e. Fractures or Dislocation)
• Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
• Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The DynaTran™ Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis

The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine from C2 – T1. These systems are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal stenosis

The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (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); and/or tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and not intended for stand-alone use.

Device Description

The previously cleared devices consist of a variety of plate systems designed to provide support across implanted levels in the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.

AI/ML Overview

This document is a 510(k) summary for several spinal plate systems, primarily aimed at establishing an "MR Conditional" labeling claim. It describes a standalone performance study to demonstrate MR compatibility.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Magnetic Resonance Safety)	Reported Device Performance (as stated in the document)
Not explicitly stated within this document. The document only references "prescribed acceptance criteria" per ASTM F2503 for MR compatibility testing.	"The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and are substantially equivalent to the predicate devices."

Note: The specific numerical or qualitative acceptance criteria defined by ASTM F2503 and applied for this submission are not detailed in the provided text. The document broadly states that the devices met these criteria.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not explicitly stated. The document refers to "the subject devices" which is a collection of 5 different plate systems, each with potentially various sizes and configurations.
Data Provenance: Not explicitly stated. The study described is a laboratory performance test (MR Compatibility testing per ASTM F2503), not a clinical study involving patient data. Therefore, concepts like country of origin or retrospective/prospective don't directly apply in the same way they would for a clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This study is a technical performance test (MR Compatibility), not a clinical study requiring expert assessment for ground truth. The "ground truth" here is the physical property of MR compatibility as defined by the ASTM standard.

4. Adjudication Method for the Test Set

Not applicable. As the study is a technical performance test, there is no adjudication process involving human reviewers. The assessment is based on objective measurements against the ASTM F2503 standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This document describes a technical MR compatibility study, not a clinical MRMC comparative effectiveness study involving human readers and AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes. The described study is a standalone performance study focused on the physical properties of the devices themselves (MR compatibility) without any human-in-the-loop component. It's a laboratory test of the device's inherent characteristics.

7. The Type of Ground Truth Used

Standardized Test Methods (ASTM F2503): The ground truth for MR compatibility is established by the specified industry standard (ASTM F2503), which outlines the methodologies and criteria for evaluating MR safety of medical implants. The "ground truth" is adherence to and performance within the limits defined by this standard.

8. The Sample Size for the Training Set

Not applicable. This is a performance study for MR compatibility, not an AI/machine learning study. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described study.

Summary

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October 19, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Stryker Corporation Katie McNeil Senior Regulatory Affairs Specialist 2 Pearl Court Allendale. New Jersev 07401

Re: K221728

Trade/Device Name: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: September 22, 2022 Received: September 22, 2022

Dear Katie McNeil:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Colin O'Neill, M.B.E Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221728

Device Name

Aviator® Anterior Cervical Plating (ACP) System

Indications for Use (Describe)

· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Trauma (including fractures)
Tumors
· Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
· Pseudarthrosis
Failed previous fusion
· Decompression of the spinal cord following total or partial cervical vertebrectomy
· Spondylolisthesis
· Spinal stenosis

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

| X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

{3}------------------------------------------------

510(k) Number (if known) K221728

Device Name LITe® Plate System Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Indications for Use (Describe)

The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);

· Pseudoarthrosis;
· Spondylolysis:
· Spondylolisthesis;
· Spinal stenosis;
Tumors:
· Trauma (i.e. Fractures or Dislocation)
· Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
· Failed Previous Fusion

The LITe® Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221728

Device Name

DynaTran™ Anterior Cervical Plating (ACP) System

Indications for Use (Describe)

· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Trauma (including fractures)
Tumors
· Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
· Pseudarthrosis
Failed previous fusion
· Decompression of the spinal cord following total or partial cervical vertebrectomy
· Spondylolisthesis
· Spinal stenosis

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------

| X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221728

Device Name Reflex™ Hybrid ACP System

Indications for Use (Describe)

The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine from C2 -T1. These systems are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Decompression of the spinal cord following total or partial cervical vertebrectomv
· Trauma (including fractures)
Tumors
· Deformities or curvatures (including kyphosis, lordosis or scoliosis)
· Pseudoarthrosis
· Failed previous fusions
· Spondylolisthesis
· Spinal stenosis

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221728

Device Name UniVise™ Spinous Process Fixation Plate

Indications for Use (Describe)

The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and not intended for stand-alone use.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{7}------------------------------------------------

510(k) Summary: Stryker Spine Plate Systems
Submitter:	Stryker Spine2 Pearl CourtAllendale, NJ 07401
Contact Person :	Name: Katie McNeilPhone: 201-749-8518Email: katie.mcneil@stryker.com
Date Prepared:	October 19, 2022
Trade Names:	1. Aviator® Anterior Cervical Plating (ACP) System2. LITe® Plate System3. DynaTran™ Anterior Cervical Plating (ACP) System4. Reflex™ Hybrid ACP System5. UniVise™ Spinous Process Fixation Plate
Common Name:	1. Aviator®Anterior Cervical Plate System2. LITe® Plate SystemAppliance, fixation, spinal intervertebral body3. DynaTran™Anterior Cervical Plate System4. Reflex™ HybridAnterior Cervical Plate System5. UniVise™ Spinous Process Fixation PlateSpinous Process Fixation Plate
Proposed Class:	Class II
Classification Name:	1. Aviator®Spinal intervertebral body fixation orthosis; 21 CFR §888.30602. LITe® Plate SystemSpinal intervertebral body fixation orthosis; 21 CFR §888.30603. DynaTran™Spinal intervertebral body fixation orthosis; 21 CFR §888.30604. Reflex™ HybridSpinal intervertebral body fixation orthosis; 21 CFR §888.30605. UniVise™ Spinous Process Fixation PlateSpinal interlaminal fixation orthosis; 21 CFR §888.3050
Product Code:	1. Aviator®KWQ2. LITe® Plate SystemKWQ3. DynaTran™KWQ
510(k) Summary: Stryker Spine Plate Systems
	4. Reflex™ HybridKWQ
	5. UniVise™ Spinous Process Fixation PlatePEK
Predicate Devices:	Primary Predicate: Aviator® (K142237)
	Additional Predicates:
	LITe® Plate System (K150449)
	DynaTran™ (K083020)
	Reflex™ Hybrid (K062310, K063430)
	UniVise™ Spinous Process Fixation Plate (K132968)
	PYRENEES, BLUE RIDGE and OZARK Cervical Plate Systems and the CAYMAN
	Thoracolumbar and Buttress Plate Systems (K182473)
Device Description:	The previously cleared devices consist of a variety of plate systems designed
	to provide support across implanted levels in the cervical, thoracolumbar,
	and lumbosacral spine until fusion is achieved.The primary purpose of this submission is to establish an MR Conditional
	labeling claim for these implants.
Intended Use:	Aviator®The Aviator® Anterior Cervical Plating System is intended for anteriorintervertebral screw fixation of the cervical spine at levels C2-T1. The systemis indicated for temporary stabilization of the anterior spine during thedevelopment of cervical spine fusions in patients with the followingindications:• Degenerative Disc Disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographicstudies)• Trauma (including fractures)• Tumors• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)• Pseudarthrosis• Failed previous fusion• Decompression of the spinal cord following total or partial cervicalvertebrectomy• Spondylolisthesis• Spinal stenosis
	LITe® Plate SystemThe LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates areindicated for use via a lateral or anterolateral surgical approach above thebifurcation of the great vessels in the treatment of the thoracic andthoracolumbar (T1-L5) spine or via an anterior approach below thebifurcation of the great vessels in the treatment of lumbar and lumbosacral(L1-S1) spine. The system is intended to provide additional support duringfusion in skeletally mature patients in the treatment of the following acuteand chronic instabilities or deformities:
510(k) Summary: Stryker Spine Plate Systems
• Degenerative Disc Disease (defined as back pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographicstudies);• Pseudoarthrosis;• Spondylolysis;• Spondylolisthesis;• Spinal stenosis;• Tumors;• Trauma (i.e. Fractures or Dislocation)• Deformities (i.e. Scoliosis, Kyphosis or Lordosis)• Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft orautograft at one level (T1-S1) as an aid to spinal fusion and to providetemporary stabilization and augment development of a solid spinal fusion. Itmay be used alone or with other anterior, anterolateral, or posterior spinalsystems made of compatible materials. This device is not intended for loadbearing applications.
DynaTran™The DynaTran™ Anterior Cervical Plating System is intended for anteriorintervertebral screw fixation of the cervical spine at levels C2-T1. The systemis indicated for temporary stabilization of the anterior spine during thedevelopment of cervical spine fusions in patients with the followingindications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographicstudies)• Trauma (including fractures)• Tumors• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)• Pseudoarthrosis• Failed previous fusion• Decompression of the spinal cord following total or partial cervicalvertebrectomy• Spondylolisthesis• Spinal stenosis
Reflex™ HybridThe Reflex™ Hybrid ACP System is intended for anterior intervertebral screwfixation of the cervical spine from C2 – T1. These systems are indicated fortemporary stabilization of the anterior spine during the development ofcervical spine fusions in patients with the following indications:
• Degenerative disc disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographicstudies)• Decompression of the spinal cord following total or partial cervical vertebrectomv
510(k) Summary: Stryker Spine Plate Systems
	• Trauma (including fractures)• Tumors• Deformities or curvatures (including kyphosis, lordosis or scoliosis)• Pseudoarthrosis• Failed previous fusions• Spondylolisthesis• Spinal stenosis
	UniVise™ Spinous Process Fixation PlateThe UniVise™ Spinous Process Fixation Plate is a posterior, non-pediclesupplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinousprocesses for the purpose of achieving supplemental fusion in the followingconditions: degenerative disc disease (defined as back pain of discogenicorigin with degeneration of the disc confirmed by history and radiographicstudies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/ortumor. The UniVise™ Spinous Process Fixation Plate is intended for use withbone graft and not intended for stand-alone use.
Summary of theTechnologicalCharacteristics	The devices in this submission possess the same technologicalcharacteristics as their predicate devices; no changes have been made to anyof the devices. Therefore, the fundamental scientific technology of thesubject devices is the same as previously cleared devices.
Summary of thePerformance Data	MR Compatibility testing per ASTM F2503 was performed. The test resultsdemonstrate that the subject devices performance met the prescribedacceptance criteria and are substantially equivalent to the predicate devices.
Conclusion	The subject devices possess the same intended use and technologicalcharacteristics as the predicate devices. Therefore, the subject devices aresubstantially equivalent.

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Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.