CAPSTONE L SPINAL SYSTEM

K123978 · Medtronic Sofamor Danek USA · MAX · Apr 9, 2013 · Orthopedic

Device Facts

• Record ID: K123978
• Device Name: CAPSTONE L SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek USA
• Product Code: MAX · Orthopedic
• Decision Date: Apr 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Intervertebral body fusion device; PEEK spacers with tantalum markers; hollow geometry for autogenous bone graft packing; non-lordotic and 6° lordotic options; teeth on superior/inferior surfaces for expulsion resistance; bullet-nosed tip for insertion. Used in lumbar/lumbo-sacral spine; implanted via minimally invasive lateral approach by surgeons; requires supplemental fixation. Provides structural support and correction during fusion surgery; benefits patients by facilitating interbody fusion in DDD cases.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including static and dynamic compression, static and dynamic compression-shear, and load-induced subsidence testing per ASTM F2077 and ASTM F2267, alongside expulsion testing.

Technological Characteristics

Materials: PEEK (ASTM F2026), tantalum markers (ASTM F560). Design: Hollow geometry, bullet-nosed tip, teeth for expulsion resistance. Options: Non-lordotic and 6° lordotic. Sterilization: Gamma irradiation. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 Spondylolisthesis or retrolisthesis, who have failed six months of non-operative treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CLYDESDALE® Spinal System (K100175)
• CLYDESDALE® Spinal System (K112405)
• CLYDESDALE® Spinal System (K113528)
• CLYDESDALE® Spinal System (K122591)
• CAPSTONE® Spinal System (K073291)

Submission Summary (Full Text)

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<123978

# CAPSTONE® L Spinal System 510(k) Summary December 21, 2012

APR 9 2013

| I. Company: | Medtronic Sofamor Danek<br>1800 Pyramid Place<br>Memphis, TN 38132<br>Telephone: [phone]<br>FAX: [phone] |
|------------------------------|------------------------------------------------------------------------------------------------------------------------|
| II. Contact: | Lauren Kamer<br>Senior Regulatory Affairs Specialist |
| III. Proprietary Trade Name: | CAPSTONE® L Spinal System |
| IV. Common Name: | Intervertebral Body Fusion Device with Bone Graft,<br>Lumbar |
| V. Classification Name: | Intervertebral Body Fusion Device (21 CFR 888.3080) |
| Class: | II |
| Product Code: | MAX |

## VI. Product Description

The CAPSTONE® L Spinal System consists of spacers of various widths and heights made of PEEK with tantalum markers. The spacers can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The implant has non-lordotic and 6° lordotic options. The superior and inferior surfaces of the implant are designed with teeth that 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 implants are provided sterile by gamma irradiation, and are to be used with supplemental fixation. CAPSTONE® L Spinal System is used with new reusable instrumentation that enables the surgeon to implant the devices via a lateral approach.

#### VII. Indications for Use

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.

sheet 1 of 3.

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These indications for use are identical to those for the predicate CLYDESDALE® Spinal System (K100175, SE Jun 2, 2010).

#### VIII. Summary of Technological Characteristics

The CAPSTONE® L Spinal System has the same fundamental scientific technology as the predicate CL YDESDALE® Spinal System. Like CLYDESDALE® Spinal System implants, CAPSTONE® L Spinal System implants are interbody fusion devices manufactured from PEEK per ASTM F2026, and include tantalum markers per ASTM F560 for imaging purposes. The implants have a non-lordotic and a 6° lordotic option, and the superior and inferior surfaces are designed with teeth that interact with the surface of the vertebral endplates to aid in resisting expulsion. The implants are designed with a bullet-nosed tip to aid in distraction and insertion into the disc space, and their hollow geometry allows them to be packed with autogenous bone graft. The implants are provided sterile by gamma irradiation, and are to be used with supplemental fixation. CAPSTONE® L Spinal System implants may be implanted via a minimally invasive lateral surgical approach.

# IX. Identification of the Legally Marketed Predicate Device Used to Claim Substantial Equivalence

In order to demonstrate substantial equivalence to legally marketed predicate devices, CLYDESDALE® Spinal System (K100175, SE Jun 2, 2010) is used as the primary predicate for intended use and fundamental scientific technology. CLYDESDALE® Spinal System 510(k)s K112405, SE Nov 21, 2011; K113528, SE Dec 20, 2011; and K122591, Sep 18, 2012, are the labeling predicates for this submission.

CAPSTONE® Spinal System (K073291, SE Apr 24, 2008) is additionally used as a predicate for this submission to demonstrate that the additional size options and mechanical performance of the subject device are substantially equivalent to other legally marketed interbody fusion devices.

#### X. Brief Discussion of the Non-Clinical Tests Submitted

An assessment of the device modifications was completed in accordance with Medtronic design control processes.

Mechanical testing was conducted according to FDA guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices", and the following standards:

- ASTM F2077: Test Methods for Intervertebral Body Fusion Devices .
- Static Compression O
- Static Compression-Shear o
- Dynamic Compression o
- Dynamic Compression-Shear 0

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- ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of the . Intervertebral Body Fusion Device under Static Axial Compression
Expulsion testing was also conducted.

All mechanical testing met the predetermined acceptance criteria.

## XI. Conclusions Drawn from the Non-Clinical Tests

A risk analysis was completed. Based on the risk analysis, mechanical testing, and additional supporting documentation provided in this premarket notification, the subject CAPSTONE® L Spinal System demonstrates substantial equivalence to the predicates CLYDESDALE® Spinal System (K100175, SE Jun 2, 2010; K112405, SE Nov 21, 2011; K113528, SE Dec 20, 2011; and K122591, Sep 18, 2012) and CAPSTONE® Spinal System (K073291, SE Apr 24, 2008).

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

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

April 9, 2013

Medtronic Sofamor Danek USA -% Ms. Lauren Kamer Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K123978

Trade/Device Name: CAPSTONE® L Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 8, 2013 Received: March 11, 2013

Dear Ms. Kamer:

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

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# Page 2 - Ms. Lauren Kamer

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 [phone] or [phone] 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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The name is written in black ink and is easily readable. The font is a sans-serif font, and the letters are all capitalized.

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): K123978

Device Name: CAPSTONE® L Spinal System

#### Indications for Use:

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.

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

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

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Concurrence of CDRH/ODE

Anton E. Dmitriev, PhD Division of Orthopedic Devices