The PERIMETER® C Spinal System is intended to be used 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 who have had six weeks of non-operative treatment. 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. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

The CAPSTONE® 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. Additionally, the CAPSTONE® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. 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 CAPSTONE® L 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 CAPSTONE® L 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 non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients 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 non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Device Description

The PERIMETER® C Spinal System consists of PEEK spacers with tantalum markers of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.

The CAPSTONE® PEEK Spinal System consists of PEEK cages with tantalum markers of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The CAPSTONE® L Spinal System consists 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. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The PERIMETER® Interbody Fusion Device consists of PEEK cages with tantalum markers of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.

AI/ML Overview

The provided document is a 510(k) premarket notification for Medtronic Sofamor Danek MRI Update for PEEK Interbody Fusion Devices. The primary purpose of this submission is to obtain MRI safety labeling for these devices and provide instructions on how to perform MRI scans on them. It asserts that the devices are "MR Conditional" according to ASTM F2503.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard Reference)	Device Performance as Reported
ASTM F2052: Measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment.	Testing completed on the worst-case implants, determining the devices are MR Conditional.
ASTM F2213: Measurement of magnetically induced torque on medical devices in the magnetic resonance environment.	Testing completed on the worst-case implants, determining the devices are MR Conditional.
ASTM F2119: Evaluation of MR image artifacts from passive implants.	Testing completed on the worst-case implants, determining the devices are MR Conditional.
ASTM F2182: Measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging.	Testing completed on the worst-case implants, determining the devices are MR Conditional.
ASTM F2503: Standard practice for marking medical devices and other items for safety in the magnetic resonance environment.	Testing completed, and devices are labeled as MR Conditional in accordance with this standard.
Substantial Equivalence: No significant changes to overall design, material, or indications from predicate devices (K122037).	The subject devices have the "same fundamental technology," are "manufactured from the same PEEK and tantalum materials," have "no changes to the overall design, to the material or the indications," and are therefore considered substantially equivalent to their predicates for MRI safety labeling.

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

Sample Size: The document repeatedly mentions "worst case implants" were used for testing. However, it does not specify the exact number of implants constitutive of this "worst case" test set for any of the ASTM standards.
Data Provenance: The document does not specify the country of origin of the data. The testing was non-clinical and conducted in accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." It's reasonable to infer the testing was conducted in a laboratory setting, likely in the USA where Medtronic Sofamor Danek is based. The data would be prospective for the purpose of this 510(k) submission, as it was specifically generated to demonstrate MRI safety for these devices.

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

This information is not provided in the document. The testing described focuses on non-clinical, objective measurements defined by ASTM standards. These standards themselves establish the "ground truth" for MR safety parameters through their methodologies. There is no mention of human experts establishing a ground truth for the test set data in the context of MRI safety.

4. Adjudication Method for the Test Set:

None specified. The testing involves physical measurements adhering to established ASTM standards, not subjective evaluation requiring adjudication by multiple experts.

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

No, an MRMC comparative effectiveness study was not done. This submission is for MRI safety labeling of interbody fusion devices, which are passive implants. An MRMC study would be relevant for diagnostic imaging interpretation or active devices with AI assistance, neither of which applies here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a passive implant (interbody fusion device), not an algorithm or an AI-powered diagnostic tool. The performance evaluated is the physical interaction of the implant with MRI fields, not an algorithm's output.

7. The Type of Ground Truth Used:

The ground truth relies on objective physical measurements and adherence to established industry standards (ASTM F2052, F2213, F2119, F2182, F2503) for assessing MRI safety of passive metallic medical implants. These standards provide the methodology and criteria for evaluating displacement force, torque, image artifacts, and RF-induced heating.

8. The Sample Size for the Training Set:

Not applicable. This is a non-clinical evaluation of a physical device's interaction with an MRI environment, not a machine learning model. 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, this question is not relevant.

Summary

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K133643N = 33 2014

510(k) SUMMARY MEDTRONIC Sofamor Danek MRI Update for PEEK Interbody Fusion Devices November 26, 2013

I. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133 、

Becky Ronner Senior Regulatory Affairs Specialist Telephone: (901) 399-2757 Fax: (901) 346-9738

Cervical Interbody Fusion Devices PERIMETER® C Spinal System (РЕЕК) Lumbar Interbody Fusion Devices CAPSTONE® PEEK Spinal System CAPSTONE® L Spinal System (PEEK) PERIMETER® Interbody Fusion Device (PEEK)

Common &Classification Names: IV.

Proprietary Trade Name:

Class:

Product Code:

Cervical & Lumbar Interbody Fusion Devices

ODP (21 CFR888.3080)	PERIMETER® C Spinal System (PEEK)
MAX (21CFR888.3080)	CAPSTONE® PEEK Spinal SystemCAPSTONE® L Spinal System (PEEK)PERIMETER® Interbody Fusion Device (PEEK)

V. Description:

a. PERIMETER® C Spinal System (PEEK)

The PERIMETER® C Spinal System consists of PEEK spacers with tantalum markers of various widths and heights, which can be inserted

II. Contact:

III.

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between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.

b. CAPSTONE® PEEK Spinal System (PEEK)

The CAPSTONE® Spinal System consists of PEEK cages with tantalum markers of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

CAPSTONE® L Spinal System c.

d. PERIMETER® Interbody Fusion Device(PEEK)

The PERIMETER® Interbody Fusion Device consists of PEEK cages with tantalum markers of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give

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support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are . designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.

Indications for Use: VI.

a. PERIMETER® C Spinal System (PEEK)

b. CAPSTONE® PEEK Spinal System

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Additionally, the CAPSTONE® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.

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.

CAPSTONE® L Spinal System (PEEK) ﻦ

d. PERIMETER® Interbody Fusion Device(PEEK)

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months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

VII. Summary of the Technological Characteristics:

The purpose of this bundled 510(k) application is to provide 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 MRI safety labeling that is being proposed has previously been cleared by FDA in submission K122037 for the following PEEK Interbody Fusion Devices:

ANATOMIC PEEK Cervical Fusion System
CORNERSTONE® PSR Spinal System
CAPSTONE CONTROL™ Spinal System
트 CLYDESDALE® Spinal System
CRESCENT® PEEK Spinal System 트
SOVEREIGN® Spinal System
TELAMON® PEEK Vertebral Body Spacer

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 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 overall design, to the material or the indications of the subject devices and are therefore substantially equivalent to their predicates.

The subject devices are substantially equivalent to the devices and 510(k)s listed below:

a. PERIMETER® C Spinal System (PEEK)

K100967 August 5th, 2011 .

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b. CAPSTONE® PEEK Spinal System Implants

K073291 April 24th, 2008 .
K121760 August 29th, 2012 .
K123027 July 25th, 2013 ●
c. CAPSTONE® L Spinal System Implants(PEEK)
- K123978 April 9th, 2013 .
d. PERIMETER® Interbody Fusion Device (PEEK) Implants
- K090353 September 29th, 2009 .
e. PEEK Interbody MRI Update (includes worst case for MRI for PEEK Interbody Devices)
- K122037 March 22nd, 2013 .

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 are 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"
ASTM F2119- "Standard test method for evaluation of MR image artifacts o from passive implants''
o ASTM F2182 "Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging"
o ASTM F2503 "Standard practice for marking medical devices and other 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/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 3, 2014

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

Re: K133645

Trade/Device Name: PERIMETER® C Spinal System, CAPSTONE® PEEK Spinal System, CAPSTONE® L Spinal System, PERIMETER® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: November 26, 2013 Received: November 27, 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

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Page 2 - Ms. Becky Ronner

device-related 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 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133645

Device Name

PERIMETER® C Spinal System

Indications for Use (Describe)

The PERIMETER® C Spinal System is intended to be used 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 who have had six weeks of non-operalive treatment. Cervical disc disease is defined and/or myelopathy with hemiated disc and/or osteoplyte formation on posterior vertebral endolates producing symptomatic nerve root and/or spinal confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

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

χ 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.

: ्र के ब्लिक का Status Comments FOR FDA USE ONLY ్ : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

David Hwang, Ph.D.

Division of Orthopedic Devices

PSC Publishing Services (301) 443-6740 12

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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"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

{11}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) KI 33645

Device Name

PERIMETER® Interbody Fusion Device

Indications for Use (Describe)

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L. to Si. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolistics at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches include anterior, lateral and oblique. These devices are intensupplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

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

: 2019-07-17 11:4

🇿 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)

. · · · · ·

David Hwang, Ph.D.

Division of Orthopedic Devices

FORM FDA 3881 (9/13)

PSC Publishing Screines (301) 441-6140 5

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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

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

{13}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133645

Device Name

CAPSTONE® PEEK Spinal System

Indications for Use (Describe)

The CAPSTONE® Spinal System is interbody fusion with autogenous bone graff 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 and radiographic studies. These patients should be skeletally mature and have bad six months of non-operative treatment.

Addinopally, the CAPSTONE® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle scerer fixation in patients diagnosed with degenerative scoliosis.

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 supplementation, which has been cleared by the FDA for use in the lunber spine.

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)

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

ਜਾਣਕਾਰ ਅਤੇ ਅੰਦਾਨ ਦੇ ਸ FOR FDA USE ONLY . . . :

FORT DANGELLONE

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

David Hwang, Ph.D.

Division of Orthopedic Devices

FORM FDA 3881 (9/13)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

OCC Bri-Nelone Soverne (2013 483-6740

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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

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

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133645

Device Name

CAPSTONE® L Spinal System

Indications for Use (Describe)

The CAPSTONE® L Spinal System is designed to be used with autogenous bone graft to facilitate interbody fission and is intended for use with supplemental fixation systems cleared for use in the lumber spine. The CAPSTONE® L Spinal System is used for patients diagased with degenerative 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 degemention of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have bad six months of non-operative treatment. These implanted via a minimally invasive lateral approach.

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

P 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 . . . . . . .. 1 2017 11: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . :

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

David Hwang, Ph.D.

Division of Orthopedic Devices

Children Services (301) 443-8740

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

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

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.