The ANATOMIC PEEK device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK device is also required to be used with autograft and is to be implanted via an open, anterior approach.

The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.

The PEEK PREVAIL™ Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The CAPSTONE CONTROLTM Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach. The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.

The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Device Description

The ANATOMIC PEEK Cervical Fusion Implants consists of cages of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in cervical interbody fusion procedures. The ANATOMIC PEEK devices are intended to be implant via an open anterior approach and used with supplemental fixation and autogenous bone graft.

The CORNERSTONE® PSR Cervical Fusion Implants consist of cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. These implants are manufactured from implant grade PEEK. The hollow geometry of the implants allows them to be packed with autogenous bone graft in cervical fusion procedures. The CORNERSTONE® PSR device is to be used with supplemental instrumentation and is to be implanted via an open, anterior approach.

The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft. The PEEK PREVAIL™ Cervical Interbody device implant is manufactured from PEEK and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.

The CAPSTONE CONTROL™ Spinal System Implants consist of PEEK cages of various widths and heights which include Tantalum markers. These implants can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE CONTROL™ Spinal System Implants are to be used with supplemental instrumentation and are to be implanted via an open or minimally invasive, posterior or transforaminal approach.

The CLYDESDALE® Spinal System Implants consist of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted via a lateral approach between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CLYDESDALE® Spinal System Implants are to be used with supplemental instrumentation.

The CRESCENT® Spinal System (PEEK) Implants consist of PEEK cages of various widths and heights which include Tantalum markers. These implants can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The CRESCENT® Spinal System Implants are to be used with supplemental instrumentation.

The SOVEREIGN® Spinal System Implants are an intervertebral body fusion devices with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN® Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted. The SOVEREIGN® Spinal System interbody device is manufactured from PEEK and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

The TELAMON® PEEK Spinal System Implants consist of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. These implants may be implanted via an open or a minimally invasive posterior approach. The TELAMON® PEEK Spinal System Implants are to be used with supplemental instrumentation.

AI/ML Overview

The provided document is a 510(k) summary for Medtronic Sofamor Danek MRI Update for PEEK Interbody Fusion Devices. The purpose of this submission is to provide appropriate MRI safety labeling for the devices and information on how to perform an MRI scan on patients with these implants. The submission determines that the devices are "MR Conditional" as per ASTM F2503.

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by ASTM Standards for MR Conditional)	Reported Device Performance (as tested)
Magnetically Induced Displacement Force (ASTM F2052): Devices should not pose a hazard due to magnetic field gradient.	Testing completed on worst-case implants provided a determination that devices are MR Conditional. (Specific forces/values not provided, but implies within acceptable limits.)
Magnetically Induced Torque (ASTM F2213): Devices should not pose a hazard due to magnetic field-induced torque.	Testing completed on worst-case implants provided a determination that devices are MR Conditional. (Specific torque values not provided, but implies within acceptable limits.)
MR Image Artifacts (ASTM F2119): Artifacts caused by the implant should not obscure critical diagnostic information.	Testing completed on worst-case implants provided a determination that devices are MR Conditional. (Specific artifact characteristics not provided, but implies acceptable for diagnostic use.)
Radiofrequency (RF) Induced Heating (ASTM F2182): Devices should not cause excessive heating during MRI.	Testing completed on worst-case implants provided a determination that devices are MR Conditional. (Specific temperature increases not provided, but implies within safe limits.)
MR Safety Labeling (ASTM F2503): Devices must be appropriately labeled for safety in the MR environment.	The devices in this submission have been determined to be MR conditional per ASTM F2503 and appropriate MRI safety labeling is being proposed.

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

Sample Size: The document states that "testing has been completed on the worst case implants." It does not specify a numerical sample size for the test set (number of individual implants tested).
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes non-clinical testing performed in accordance with ASTM guidance. This implies laboratory testing rather than human subject data.

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

This information is not applicable to this submission. The "ground truth" here is established by the specified ASTM standards for MRI safety of implants, not by expert interpretation of data generated by the device. The testing involved physical measurements and evaluations according to these standards.

4. Adjudication Method for the Test Set

This information is not applicable. As the testing is non-clinical and based on physical measurements and adherence to ASTM standards, there is no need for adjudication by multiple readers or a consensus process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on the MRI safety of the implanted devices themselves, not on an AI system assisting human readers in interpreting medical images.

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

No, a standalone algorithm performance study was not done. This submission is for physical medical devices—interbody fusion implants—and their safety in an MRI environment, not for an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this assessment is defined by the ASTM International Standards for evaluating the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment:

ASTM F2052
ASTM F2213
ASTM F2119
ASTM F2182
ASTM F2503

These standards outline the methodologies and acceptable limits for magnetic displacement, torque, RF heating, and image artifacts.

8. The Sample Size for the Training Set

This information is not applicable. This submission is not about an AI/ML algorithm that requires training data. It is about the physical properties of medical implants.

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

This information is not applicable for the same reason as point 8.

Summary

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510(k) SUMMARY MEDTRONIC Sofamor Danek MRI Update for PEEK Interbody Fusion Devices July 2012

I. Medtronic Sofamor Danek, Company: USA Inc. 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133 II. Contact: Becky Ronner Regulatory Affairs Specialist Telephone: (901) 399-2757 Fax: (901) 346-9738

III. Proprietary Trade Name: Cervical Interbody Fusion Devices ANATOMIC PEEK Cervical Fusion System CORNERSTONE® PSR Cervical Fusion System PEEK PREVAIL® CERVICAL INTERBODY DEVICE

Lumbar Interbody Fusion Devices CAPSTONE® CONTROL Spinal System CLYDESDALE® Spinal System CRESCENT® Spinal System (PEEK) SOVEREIGN® Spinal System TELAMON® PEEK Spinal System

IV. Common &Classification Names: Cervical & Lumbar Interbody Fusion Devices

Class:

MAR 2 2 2013

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Product Code:

ODP (21 CFR888.3080)	ANATOMIC PEEK Cervical FusionSystemCORNERSTONE® PSR CervicalFusion System
OVE (21 CFR888.3080)	PEEK PREVAIL® CERVICALINTERBODY DEVICE
MAX (21 CFR888.3080)	CAPSTONE® CONTROL SpinalSystemCLYDESDALE® Spinal SystemCRESCENT® Spinal System(PEEK)TELAMON® PEEK Spinal System
OVD (21 CFR888.3080)	SOVEREIGN® Spinal System

V. Description:

a. ANATOMIC PEEK Cervical Fusion Implants

b. CORNERSTONE® PSR Cervical Fusion Implants

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c. PEEK PREVAIL™ Cervical Interbody Device

The PEEK PREVAIL™ Cervical Interbody device implant is manufactured from PEEK and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.

d. CAPSTONE® CONTROL Spinal System Implants

e. CLYDESDALE® Spinal System Implants

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f. CRESCENT® Spinal System (PEEK) Implants

The CRESCENT® Spinal System Implants consist of PEEK cages of various widths and heights which include Tantalum markers. These implants can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The CRESCENT® Spinal System Implants are to be used with supplemental instrumentation.

g. SOVEREIGN® Spinal System Implants

The SOVEREIGN® Spinal System interbody device is manufactured from PEEK and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

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h. TELAMON® PEEK Spinal System Implants

VI. Indications for Use:

a. ANATOMIC PEEK Cervical Fusion Implants

b. CORNERSTONE® PSR Cervical Fusion Implants

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radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.

PEEK PREVAIL™ Cervical Interbody Device ﻦ

d. CAPSTONE® CONTROL Spinal System Implants

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are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

CLYDESDALE® Spinal System Implants e.

f. CRESCENT® Spinal System (PEEK) Implants

The CRESCENT® Spinal System is indicated for interbody fusion with . autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

g. SOVEREIGN® Spinal System Implants

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with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.

The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.

When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.

h. TELAMON® PEEK Spinal System Implants

These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

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VII. Summary of the Technological Characteristics:

The purpose of this bundled 510(k) application is to provide appropriate MRI safety labeling for the subject devices, while also providing MRI technologists with a method of concluding whether an MRI scan can be performed on the device and specific instructions on how to perform the scan. The systems in this 510(k) submission have been determined to be MR conditional per ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

The labeling that is being proposed has previously been cleared by FDA in submission K I 10063 for SOVEREIGN® Spinal System Implants. All the subject devices within this bundled submission have the same fundamental technology. They are intended to provide correction and stabilization during intervertebral body fusion procedures for treatment of degenerative disc disease. They are all generally manufactured from the same PEEK and tantalum materials and have been designed to be used with autogenous bone graft. There have been no changes to the design, to the material or the indications of the subject devices and are therefore identical to their predicates.

The design/specifications of the subject devices are not being addressed. No changes have occurred for the devices in the subject product families which are considered substantially equivalent to and previously cleared under previous 510(k) submissions such as:

a. ANATOMIC PEEK Cervical Fusion System K112444 (SE 11/15/2011)
b. CORNERSTONE® PSR Cervical Fusion System K100214 (SE 06/25/2010), K111264 (SE 10/12/2011)
c. PEEK PREVAIL® Cervical Interbody Device K073285 (SE 05/15/2008), K094042 (SE 06/30/2010), K113252 (SE 01/17/2012), K030327(SE 02/26/2003)
d. CAPSTONE® CONTROL Spinal System K120368 (04/09/2012)

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e. CLYDESDALE® Spinal Svstem K113528 (SE 12/20/2011), K100175 (SE 06/02/2010), K083026 (SE 12/29/2008)
f. CRESCENT® Spinal System (PEEK) K094025 (SE 04/26/2010)
g. SOVEREIGN® Spinal System K091813 (SE 11/17/2009), K110063 (SE 10/04/2011)
h. TELAMON® PEEK Spinal System K110562 (SE 11/09/2011)

IX. Discussion of Non-Clinical Testing:

In accordance FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" testing has been completed on the worst case implants. The following testing has been completed and provided a determination that the subject devices in this 510(k) submission have been determined to be MR conditional:

o ASTM F2052 "Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment"
o ASTM F2213 "Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment"
o ASTM F2119 "Standard test method for evaluation of MR image artifacts from passive implants"
ASTM F2182 "Standard test method for measurement of radio frequency o induced heating on or near passive implant during magnetic resonance imaging"
ASTM F2503 "Standard practice for marking medical devices and other o items for safety in the magnetic resonance environment"

X. Conclusion:

Non-clinical testing in accordance with the standards listed above was completed along with a risk analysis. Based on the test results and additional

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supporting documentation provided within this pre-market notification, Medtronic believes that the subject devices demonstrate substantial equivalence to the listed predicate device and should be labeled as MR Conditional in accordance with ASTM F2503 – "Standard practice for marking medical devices and other items for safety in the magnetic resonance environment'.

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Image /page/11/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is represented by a triple-stranded helix.

Public Health Service

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

March 22, 2013

Medtronic Sofamor Danek USA, Incorporated % Ms. Becky Ronner Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K122037

Trade/Device Name: ANATOMIC PEEK CERVICAL FUSION SYSTEM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class H Product Code: MAX, ODP, OVE, OVD Dated: February 20, 2013 Received: February 21, 2013

Dear Ms. Ronner:

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

{12}------------------------------------------------

Page 2 - Ms. Becky Ronner

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/12/Picture/6 description: The image shows the name "Erin I.D.Keith" in a stylized font. The letters "I.D.K" are designed with a layered, geometric pattern, giving them a unique visual texture. The rest of the letters are in a bold, sans-serif font, creating a contrast with the central part of the name.

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

Enclosure

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510(k) Number (if known): K122037

Device Name: ANATOMIC PEEK CERVICAL FUSION SYSTEM

Indications for Use:

The ANATOMIC PEEK CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is to be used with any cleared supplemental fixation device for cervical. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach."

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number (if known): K122037

Device Name: CORNERSTONE® PSR Cervical Fusion System

Indications for Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{15}------------------------------------------------

510(k) Number (if known): __K122037

Device Name: PEEKPREVAIL® Cervical Interbody Device

Indications for Use:

The PEEK PREVAIL™ Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAILTM Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{16}------------------------------------------------

510(k) Number (if known): _K122037

Device Name: CAPSTONE® CONTROL Spinal System

Indications for Use:

The CAPSTONE CONTROL™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number (if known): K122037

Device Name: CLYDESDALE® Spinal System

Indications for Use:

The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number (if known): _K122037

Device Name: CRESCENT® Spinal System (PEEK)

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number (if known): K122037

Device Name: SOVEREIGN® Spinal System

Indications for Use:

The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.

Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number (if known): K122037

Device Name: TELAMON® PEEK Spinal System

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.