CAPSTONE R SPINAL SYSTEM

K103731 · Medtronic Sofamor Danek · MAX · Jul 18, 2011 · Orthopedic

Device Facts

• Record ID: K103731
• Device Name: CAPSTONE R SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: MAX · Orthopedic
• Decision Date: Jul 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAPSTONE® Spinal System is indicated for use 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 I 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.

Device Story

CAPSTONE® Spinal System consists of PEEK, titanium alloy, and titanium cages; designed for insertion between lumbar or lumbosacral vertebral bodies to provide support and correction during interbody fusion. Hollow geometry allows containment of autogenous bone graft. Implanted by surgeons via open or minimally invasive posterior, anterior, or transforaminal approaches. Requires use with supplemental fixation instrumentation cleared for lumbar spine. Device provides structural support to facilitate fusion in DDD patients.

Clinical Evidence

No clinical data. Bench testing only; cleaning and sterilization validation performed for the new threaded inserter instrument.

Technological Characteristics

Intervertebral body fusion device; materials include PEEK and titanium alloy. Hollow geometry for bone graft containment. Includes threaded inserter instrument. No electronic, software, or energy-based components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two levels from L2 to S1, including those with up to Grade 1 Spondylolisthesis or retrolisthesis. Requires history of discogenic back pain, radiographic confirmation, and failure of 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

• CAPSTONE® Spinal System (K103731)

Submission Summary (Full Text)

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K103731 page 1 of 2

# CAPSTONE® Spinal System 510(k) Summary 6/24/2011

JUL 18 2011

- Medtronic Sofamor Danek Company: I. 1800 Pvramid Place Memphis, TN 38132 [phone]
Thao Phan Contact: Regulatory Affairs Specialist

- Proprietary Trade Name: CAPSTONE® Spinal System II.
Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080) III.

- IV. Product Code: MAX
#### V. Product Description

The CAPSTONE® Spinal System consists of Polyetheretherketone (PEEK) cages, titanium alloy and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction of the lumbar spine during lumbar interbody fusion surgeries. The hollow geometry of the CAPSTONE® implants allows them to hold autogenous bone graft material.

## VI. Indications

The CAPSTONE® Spinal System is indicated for use 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.

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K103731 Page 2 of 2

#### VII. Substantial Equivalence

Documentation was provided which demonstrated that the subject CAPSTONE® Spinal System device is substantially equivalent to the predicate CAPSTONE® Spinal System device.

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

A new threaded inserter instrument was added to the CAPSTONE® Spinal System and cleaning and disassembly instructions for the new instrument were added to the labeling. The subject and predicate CAPSTONE® Spinal System devices are identical in terms of indications for use, intended use, performance specifications, and technological characteristics. Cleaning and sterilization validation activities have been conducted to provide the appropriate cleaning and sterilization instructions for the CAPSTONE® Spinal System.

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

The information above demonstrates equivalence and supports a determination of substantial equivalence between the subject and predicate CAPSTONE® Spinal System devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

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

JUL 1 8 2011

Re: K103731

Trade/Device Name: CAPSTONE® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 24, 2011 Received: June 27, 2011

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

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Page 2 - Ms. Becky Ronner

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 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/ucm115809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ernel Keith

J Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K103731

Device Name: CAPSTONE® Spinal System

# Indications for Use:

The CAPSTONE® Spinal System is indicated for use 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 I 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 X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 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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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIO3731 510(k) Number__