The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scolosis, Scheuermann's Disease), tumor, stenoss, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusionenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct Java® System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.

In order to achieve additional levels of fixation the Vitality® Spinal Fixation System rods may be connected to the Instinct Java® System (05.5mm rod) or the Virage® OCT Spinal Fixation System (03.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct Java® System and Virage® OCT Spinal Fixation System package inserts for instructions for use.

Vitality®+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws using a power surgical technique. Pedicle and iliac screws from the Vitality® Spinal Fixation System may be implanted in the non-cervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.

Device Description

The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.

The system also includes instrumentation for insertion and removal and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality® Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java "Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.

The Vitality®+ Power Instrument System includes instrumentation to be used with power for the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws. The system includes reusable Vitality drills, taps, drivers and adapters to be used with an electric handpiece. The subject instruments are compatible for use with the Vitality® Spinal Fixation System implants.

The proposed instruments subject of this submission are intended for exclusive use with Zimmer Biomet Universal Power System.

AI/ML Overview

The FDA 510(k) summary for the Vitality® Spinal Fixation System and Vitality®+ Power Instrument System describes non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and performance metrics for an AI device. The document pertains to a medical device for spinal fixation, explicitly mentioning implants, instruments, and surgical techniques, not an AI or algorithm-based system.

Therefore, many of the requested categories related to AI performance metrics (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this document. The provided text does not contain information on an AI device.

However, I can extract the information relevant to the non-clinical testing performed for the substantial equivalence determination of the Vitality® Spinal Fixation System and Vitality®+ Power Instrument System.

Acceptance Criteria and Device Performance for Vitality® Spinal Fixation System & Vitality®+ Power Instrument System:

Acceptance Criteria Category	Reported Device Performance/Study Conclusion
Substantial Equivalence	The non-clinical testing and analysis demonstrated that the subject Vitality® Spinal Fixation System (with Vitality®+ Power instruments) is substantially equivalent to the predicate Vitality® Spinal Fixation System (K171907), Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632), and Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679).
Safety & Efficacy (compared to predicates)	Based on the testing and analysis, the subject device does not raise any new issues regarding safety or efficacy when compared to its predicates.
Non-Clinical Testing Performed	- Cadaveric Testing- Clinical Literature Assessment
Intended Use/Indications for Use	The Vitality® Spinal Fixation System is a non-cervical spinal fixation device for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5) in skeletally mature and adolescent patients. It is an adjunct to fusion for indications like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, pseudoarthrosis, and/or failed previous fusion. Also indicated for severe spondylolisthesis (Grade 3 and 4) of L5-S1. Pediatric pedicle screw fixation is limited to a posterior approach for adolescent idiopathic scoliosis. The Vitality®+ Power Instrument System is intended for use with the Zimmer Biomet Universal Power System to facilitate preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws using a power surgical technique in non-cervical spine procedures (open and minimally invasive).
Materials	Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Instruments are reusable.
Sterility	Assumed to meet industry standards as part of overall substantial equivalence, though not explicitly detailed with specific data in this summary.
Manufacturing Methods	Same or similar to predicate devices.
Operational Principles	Substantially equivalent to predicate devices.

Additional Information (where applicable based on the provided document):

Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical testing for a physical medical device, not an AI algorithm evaluated on a data test set. The tests mentioned are "Cadaveric Testing" and "Clinical Literature Assessment," but no specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are provided for these.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe the evaluation of an AI device with a ground truth established by experts.
Adjudication method for the test set: Not applicable. No adjudication method for an AI test set is described.
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 is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The concept of "ground truth" in the context of AI evaluation does not apply to this device. The evaluation focuses on physical performance and substantial equivalence to existing devices.
The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable. This document describes a physical medical device, not an AI algorithm.

Summary

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Image /page/0/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a single, abstract shape.

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

September 27, 2017

Zimmer Biomet Spine, Inc. Ms. Kelly Stratton Regulatory Affairs Specialist 10225 Westmoor Drive Westminster, Colorado 80021

Re: K172275

Trade/Device Name: Vitality® Spinal Fixation System, Vitality®+ Power Instrument System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: July 27, 2017 Received: July 28, 2017

Dear Ms. Stratton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Ronald P. Jean - S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K172275

Device Name Vitality® Spinal Fixation System

Indications for Use (Describe)

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

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

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known)

K172275

Device Name Vitality®+ Power Instrument System

Indications for Use (Describe)

Intended Use (Power):

Indications for Use (Power):

The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scolosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fitality® Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusione graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. The Vitality® System is intended to be used with autograft and or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/6/Picture/0 description: The image shows the Zimmer Biomet logo, which includes a stylized blue "Z" inside a circle, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. Below the company name, the text "K172275" is displayed, followed by "Page 1 of 5". This suggests that the image is part of a document or report, possibly related to a medical device or procedure.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date	September 13, 2017
Applicant/Sponsor	Zimmer Biomet Spine, Inc.10225 Westmoor Dr.Westminster, CO 80021
Contact Person	Kelly StrattonRegulatory Affairs SpecialistPhone: 303-501-8386Fax: 303-501-8444
Trade Name	Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
Common Name	Pedicle Screw Spinal System
Device Class	Class II
Classification Name	Thoracolumbosacral Pedicle Screw System (NKB)Class II per 21 CFR §888.3070Appliance, Fixation, Spinal Interlaminal (KWP)Class II per 21 CFR §888.3050Appliance, Fixation, Spinal Intervertebral Body (KWQ)Class II per 21 CFR §888.3060
Device Panel	Orthopedic

Device Description & Technological Characteristics:

1. Vitality® Spinal Fixation System

The system also includes instrumentation for insertion and removal and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical

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Image /page/7/Picture/0 description: The image shows the Zimmer Biomet logo, which includes a stylized blue "Z" inside a circle, followed by the text "ZIMMER BIOMET" in gray. Below the logo and text, the text "K172275" is displayed, followed by "Page 2 of 5". The text is in a smaller font size than the company name.

grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality® Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java "Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.

2. Vitality®+ Power Instrument System

The proposed instruments subject of this submission are intended for exclusive use with Zimmer Biomet Universal Power System.

Intended Use/ Indications for Use

1. Vitality® Spinal Fixation System

The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The Vitality® System is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp®

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Image /page/8/Picture/0 description: The image shows the Zimmer Biomet logo, along with the text "K172275 Page 3 of 5". The logo consists of a blue circle with a stylized "Z" inside, followed by the company name in gray. The text below the logo indicates a document identifier and page number.

(titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.

In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use.

2. Vitality®+ Power Instrument System

Intended Use (Power):

Pedicle and iliac screws from the Vitality® Spinal Fixation System may be implanted in the noncervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.

Indications for Use (Power):

The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are 13sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The

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Image /page/9/Picture/0 description: The image shows the Zimmer Biomet logo, with the text "ZIMMER BIOMET" in gray. Below the logo, the text "K172275" and "Page 4 of 5" are printed in a smaller font size. The logo consists of a stylized letter Z inside a circle.

Vitality® System is intended to be used with autograft. Pediatric pediale screw fixation is limited to a posterior approach.

Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.

Summary of Technological Characteristics:

1. Vitality® Spinal Fixation System

The technological characteristics of the subject Vitality® Spinal Fixation System remain the same as, or similar to, the predicate Vitality® Spinal Fixation System (K171907) in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, materials, and operational principles.

2. Vitality®+ Power Instrument System

The subject Vitality®+ Power Spinal Fixation System includes instrumentation to be used with power for the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws. The subject system has the same technological characteristics as predicates Vitality® Spinal Fixation System (K171907), Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632), and Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679) in terms of design, fundamental technology, materials and manufacturing methods. The performance characteristics and operational principles are substantially equivalent.

Summary of Non-Clinical Testing / Performance Data:

Nonclinical testing was performed to demonstrate that the subject Vitality® Spinal Fixation System with Vitality®+ Power instruments is substantially equivalent to other predicate devices. The following testing and analysis was performed:

Cadaveric Testing .
Clinical Literature Assessment

Predicates:

Primary Predicate: Vitality® Spinal Fixation System (K171907) Additional Predicates:

Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632)

Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679)

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Image /page/10/Picture/0 description: The image shows the Zimmer Biomet logo, which includes a stylized letter Z inside a circle. Below the logo are the alphanumeric characters "K172275" and the text "Page 5 of 5". The text likely indicates a document identifier and page number within a larger document.

Substantial Equivalence:

The results from the non-clinical testing and analysis show that the subject Vitality® Spinal Fixation System is substantially equivalent to the Vitality® Spinal Fixation System (K171907), Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632), and Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679).

Conclusion:

The Vitality® Spinal Fixation System is substantially equivalent to the predicate system as a spinal fixation device in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, cadaveric testing and clinical literature assessment sufficiently demonstrate the substantial equivalence of the subject components to the Vitality® Spinal Fixation System, which has been cleared for non-cervical spinal fixation. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
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.
(b)
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.