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 purposes 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 is not intended for stand alone use.

Device Description

The UniVise™ Spinous Process Fixation Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The S.P.F.P is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6Al-4V alloy. The UniVise™ Spinous Process Fixation Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the S.P.F.P is available for both conventional and minimally-invasive surgical procedures. When the UniVise™ Spinous Process Fixation Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).

AI/ML Overview

Please find the acceptance criteria and study information for the UniVise™ Spinous Process Fixation Plate below:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices	"The UniVise™ Spinous Process Fixation Plate is substantially equivalent and has equivalent technological characteristics to other predicate devices cleared by the FDA as demonstrated through comparison in areas such as design, labeling, intended use, material composition, and function."
Safety and Effectiveness	"The UniVise™ Spinous Process Fixation Plate is as safe and effective as the predicate devices as it has the same intended uses and similar indications for use, technological characteristics, and principles of operation as its predicate devices."

2. Sample size used for the test set and the data provenance

No specific test set or data provenance is mentioned in the provided text. The submission is a 510(k) for a modification to the surgical technique of an already cleared device, and no new performance data was generated. The claim of substantial equivalence is based on comparison to predicate devices, not on new testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The submission is focused on demonstrating substantial equivalence to predicate devices, not on a study requiring expert-established ground truth.

4. Adjudication method for the test set

Not applicable. There was no test set requiring adjudication in this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical implant (Spinous Process Fixation Plate), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This device is a medical implant, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used

The "ground truth" for this submission is substantial equivalence to legally marketed predicate devices. This is established through comparative analysis of design, labeling, intended use, material composition, and function, rather than an independent clinical or pathological ground truth as would be used for a diagnostic device.

8. The sample size for the training set

Not applicable. The submission refers to a medical implant and its surgical technique, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. There was no training set in this submission.

Summary

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510(k) Summary: UniVise™ Spinous Process Fixation Plate
Submitter:	Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Contact Person	Kristen Meany, MS, CQA, RACProject Manager, Regulatory AffairsPhone: 201-760-8070Fax: 201-962-4070Email: kristen.meany@stryker.com
Date Prepared	September 20 2013
Trade Name	UniVise™ Spinous Process Fixation Plate
Common Name	Spinous Process Fixation Plate
Proposed Class	Class II
Classification Nameand Number	Spinal interlaminal fixation orthosis, 21 C.F.R. 888.3050
Product Code	PEK
Predicate Devices	The UniVise™ Spinous Process Fixation Plate was shown to besubstantially equivalent to the devices listed below:• Affix® Spinous Process Plate System, NuVasive Incorporated,K131238• VertiFlex® Spinous Fixation Plate, VertiFlex Incorporated,K122509
Device Description	The UniVise™ Spinous Process Fixation Plate is a one-piece bilaterallocking plate device which attaches to the posterior non-cervical spineby securely grasping two adjacent spinous processes. The S.P.F.P isavailable in multiple sizes to accommodate different anatomicalrequirements, and it is composed entirely of titanium 6Al-4V alloy. TheUniVise™ Spinous Process Fixation Plate may be implanted by eitherconventional surgical methods, or via minimally-invasive techniques.Proprietary manual instrumentation for implantation of the S.P.F.P isavailable for both conventional and minimally-invasive surgicalprocedures. When the UniVise™ Spinous Process Fixation Plate is usedas supplemental fixation in interbody fusion procedures, its use islimited to the treatment of degenerative disc disease (DDD) of thelumbosacral spine (L2-S1).
Intended Use	The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level inthe non-cervical spine (T1-S1). It is intended for platefixation/attachment to spinous processes for the purposes of achievingsupplemental fusion in the following conditions: Degenerative discdisease (defined as back pain of discogenic origin with degeneration ofthe 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 withbone graft and is not intended for stand alone use

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Summary of the TechnologicalCharacteristics	As was established in this submission, the UniVise™ SpinousProcess Fixation Plate is substantially equivalent and hasequivalent technological characteristics to other predicatedevices cleared by the FDA as demonstrated throughcomparison in areas such as design, labeling, intended use,material composition, and function.
Summary of the PerformanceData	The purpose of this 510(k) is to modify the SurgicalTechnique for the subject UniVise™ Spinous ProcessFixation Plate. No device design changes have been made tothe predicate VertiFlex® Spinous Process Fixation Plate(commercially distributed as the UniVise™ Spinous ProcessFixation Plate by Stryker Spine) previously cleared inK122509. No new performance data was generated for thepurpose of this submission.
Conclusions	The UniVise™ Spinous Process Fixation Plate is as safe andeffective as the predicate devices as it has the same intendeduses and similar indications for use, technologicalcharacteristics, and principles of operation as its predicatedevices.

Summary of the TechnologicalCharacteristics

As was established in this submission, the UniVise™ SpinousProcess Fixation Plate is substantially equivalent and hasequivalent technological characteristics to other predicatedevices cleared by the FDA as demonstrated throughcomparison in areas such as design, labeling, intended use,material composition, and function.

Summary of the PerformanceData

The purpose of this 510(k) is to modify the SurgicalTechnique for the subject UniVise™ Spinous ProcessFixation Plate. No device design changes have been made tothe predicate VertiFlex® Spinous Process Fixation Plate(commercially distributed as the UniVise™ Spinous ProcessFixation Plate by Stryker Spine) previously cleared inK122509. No new performance data was generated for thepurpose of this submission.

Conclusions

The UniVise™ Spinous Process Fixation Plate is as safe andeffective as the predicate devices as it has the same intendeduses and similar indications for use, technologicalcharacteristics, and principles of operation as its predicatedevices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, symbolizing strength and freedom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle, emphasizing the department's name and national affiliation.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2013

Stryker Spine Kristen Meany, MS, CQA, RAC Project Manager, Regulatory Affairs 2 Pearl Court Allendale, New Jersey 07401

Re: K132968

Trade/Device Name: UniViseTM Spinous Process Fixation Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 26, 2013 Received: September 27, 2013

Dear Ms. Meany:

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. Isting 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set .

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Page 2 - Kristen Meany, MS, CQA, RAC

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Ronaldillean -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 Statement

510(k) Number (if known): K132968

Device Name: Stryker Spine UniVise™ Spinous Process Fixation Plate

Indications for Use:

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 is not intended for stand-alone use.

Prescription Use X (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132968

Page __ of

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.