CAPSTONE CONTROL SPINAL SYSTEM

K120368 · Medtronic Sofamor Danek USA, Inc. · MAX · Apr 9, 2012 · Orthopedic

Device Facts

• Record ID: K120368
• Device Name: CAPSTONE CONTROL SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Intervertebral body fusion device; PEEK cage with tantalum markers; inserted between lumbar/lumbosacral vertebral bodies to provide support/correction during fusion surgery; hollow geometry packed with autogenous bone graft; implanted via open, minimally invasive posterior, anterior, or transforaminal approaches; used with supplemental fixation instrumentation; provides structural support to facilitate fusion; benefits patients by stabilizing spinal segments and reducing discogenic pain.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077-11 and ASTM F2267-04, including static compression, dynamic compression fatigue, static compression shear, dynamic compression shear fatigue, subsidence, and rotational testing. All results met predetermined acceptance criteria.

Technological Characteristics

Intervertebral body fusion device; material: Zeniva ZA-500 PEEK with tantalum markers; geometry: convex, bullet-nosed, hollow; dimensions: 8-18mm height, 22-32mm length, 9-10mm width; lordosis options: 0°, 6°, 12°, 18°; mechanical testing standards: ASTM F2077-11, ASTM F2267-04.

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, 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

• CAPSTONE® Spinal System (K073291, K103731)
• BoneBac™ T-PLIF Invertebral Body Fusion Device System (K111512)
• HOURGLASS® Spinal System (K033926)
• CoRoent™ (K071795)
• PERIMETER® Spinal System (K090353)
• CRESCENT™ Spinal System (K094025)

Submission Summary (Full Text)

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K120368 Page 1/4

APR - 9 2012

# 510(k) Summary

# MEDTRONIC Sofamor Danek CAPSTONE CONTROL™ SPINAL SYSTEM February 3, 2012

| I. | Company: | Medtronic Sofamor Danek, USA Inc. |
|------|-------------------------------------|-----------------------------------------|
| | | 1800 Pyramid Place |
| | | Memphis, Tennessee 38132 |
| | | [phone] |
| II. | Contact: | Julie Bassett |
| | | Principal Regulatory Affairs Specialist |
| | | Telephone: [phone] |
| | | Fax: [phone] |
| III. | Proposed Proprietary<br>Trade Name: | CAPSTONE CONTROL™ Spinal System |
| IV. | Classification Names: | Intervertebral Body Fusion Device |
| | | (21 CFR 888.3080) |
| | Class: | II |
| | Product Code: | MAX |

#### V. Description:

The CAPSTONE CONTROL™ Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar

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interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The CAPSTONE CONTROL™ Spinal System implants will be available in heights of 8mm to 18mm, lengths of 22mm, 27, mm, and 32mm, and widths of 9mm or 10mm. In addition, the implants will be available with 0°, 6°, 12°, and 18° of lordosis.

#### VI. Indications for Use:

The CAPSTONE CONTROL™ Spinal System has the same indications for use as the predicate CAPSTONE® Spinal System. 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 nonoperative 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.

#### VII. Summary of the Technological Characteristics:

The CAPSTONE CONTROL™ Spinal System has the same fundamental technology as the predicate CAPSTONE® Spinal System. The CAPSTONE CONTROL™ Spinal System implants (subject device) and the CAPSTONE® Spinal System implants (predicate device), are both made from Zeniva ZA-500 PEEK material with tantalum markers. The predicate and subject devices are

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also both convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.

#### Identification of Legally Marketed Devices: VIII.

The CAPSTONE CONTROL™ Spinal System has the same indications for use and fundamental scientific technology as the predicate, CAPSTONE® Spinal System (K073291, SE 4/24/2008 and K103731, SE 07/18/2011).

Additional predicates are being used to demonstrate that the additional size options and features are not new and currently exist in other legally marketed devices. These predicates include:

- K111512 BoneBac™ T-PLIF Invertebral Body Fusion Device System by . Thompson MIS (SE 10/26/2011)
- K033926 HOURGLASS® Spinal System by Medtronic (SE 10/26/04) .
- K071795 CoRoent™ by Nuvasive, (SE 12/4/2007) .
- K090353 PERIMETER® Spinal System by Medtronic (SE 8/29/2009) ●
- K094025 CRESCENT™ Spinal System by Medtronic (SE 4/26/2010) .

#### Discussion of Non-Clinical Testing: IX.

In order to demonstrate substantial equivalence to the predicate devices, FDA's Guidance document, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007, was used. In addition, mechanical testing was conducted on the subject CAPSTONE CONȚROL™ Spinal System in accordance with ASTM F2077-11: Test Methods for Intervertebral Body Fusion Devices and ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression. These tests included static compression testing, dynamic compression fatigue testing, static compression shear testing, dynamic compression shear fatigue testing, and subsidence. Due

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to the "insert and rotate" feature of the implants, rotational testing was also performed. All testing met the predetermined acceptance criteria and demonstrated that the subject device was as safe and effective as the predicate devices.

#### XI. Conclusion:

Based on the risk analysis, test results, and additional supporting documentation provided in this pre-market notification, the subject CAPSTONE CONTROL™ Spinal System is the subject device is as safe and effective as the predicates, CAPSTONE® Spinal System (K073291, SE 4/24/2008 and K103731, SE 07/18/2011), K111512 – BoneBac™ T-PLIF Invertebral Body Fusion Device System by Thompson MIS (SE 10/26/2011), K033926 – HOURGLASS® -Spinal System by Medtronic (SE 10/26/04), K071795 - CoRoent™ by Nuvasive, (SE 12/4/2007), K090353 - PERIMETER® Spinal System by Medtronic (SE 8/29/2009), and K094025 - CRESCENT™ Spinal System by Medtronic (SE 4/26/2010).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The logo is black and white.

### Public Health Service

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

Medtronic Sofamor Danek USA, Inc. % Ms. Julie Bassett Principal Regulatory Affairs Specialist 1800 Pyramid Place : Memphis, Tennessee 38132

Re: K120368

Trade/Device Name: CAPSTONE CONTROL™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: February 3, 2011 Received: February 6, 2012

Dear Ms. Bassett:

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

APR - 9 2012

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### Page 2 - Ms. Julie Bassett

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 vours.

Eunice Keith

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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### 21203108 510(k) Number (if known):

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) 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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI20368 510(k) Number_

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