CAPSTONE(R) SPINAL SYSTEM

K123027 · Medtronic Sofamor Danek, Inc. · MAX · Jul 25, 2013 · Orthopedic

Device Facts

• Record ID: K123027
• Device Name: CAPSTONE(R) SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jul 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K123027 · Jul 25, 2013	CAPSTONE(R) SPINAL SYSTEM	Medtronic Sofamor Danek, Inc.	Published retrospective clinical data	The sponsor provided published retrospective clinical data to demonstrate that the use of interbody cages to treat deformity conditions (degenerative scoliosis) poses no new risks to patients.	Retrospective clinical data; Degenerative scoliosis; Safety assessment

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Published retrospective clinical data; Retrospective clinical study	Patients with deformity conditions (degenerative scoliosis)	Not applicable for this study	Safety (no new risks)

Indications for Use

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.

Device Story

CAPSTONE® Spinal System consists of PEEK interbody cages; hollow geometry allows packing with autogenous bone graft. Implants inserted between lumbar or lumbosacral vertebral bodies to provide support and correction during fusion surgery. Used in open or minimally invasive posterior, anterior, or transforaminal approaches. Requires supplemental fixation instrumentation cleared for lumbar spine. Intended to facilitate fusion between vertebral bodies. Surgeon-operated in clinical/OR setting. Benefits include structural support and fusion facilitation in DDD and degenerative scoliosis patients.

Clinical Evidence

No new clinical trials performed. Evidence consists of published retrospective clinical data for the CAPSTONE® system and similar interbody cages, demonstrating that use in deformity conditions poses no new patient risks.

Technological Characteristics

PEEK interbody cages; hollow geometry for bone graft containment. Convex, bullet-nosed form factor. Implanted via posterior, anterior, or transforaminal approaches. No changes to materials, design, or sterilization methods from predicate devices.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two levels (L2-S1), including those with up to Grade 1 Spondylolisthesis or retrolisthesis, who have failed six months of non-operative treatment. Also indicated for use as a supplement to pedicle screw fixation in patients with degenerative scoliosis.

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

• K121760
• K120368
• K103731
• K082732

Submission Summary (Full Text)

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## CAPSTONE® Spinal System 510(k) Summary - K123027

### July 2013

## JUL 2 5 2013

| Company: | Medtronic Sofamor Danek USA<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
|----------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lee Grant |

# Proposed Proprietary Trade Name: CAPSTONE® Spinal System

Classification Name(s): Intervertebral Body Fusion Device (per 21CFR Section 888.3080); Product Code: MAX

Distinguished Regulatory Affairs Advisor

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

The purpose of this 510(k) submission is to expand the indications of the CAPSTONE® Spinal System to allow the device to be used a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.

Indications for Use: 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.

Summary of the Technological Characteristics: The CAPSTONE® Spinal System implants contained in this application are identical to those previously cleared in earlier 510(k) applications. The devices are convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies. The

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fundamental scientific technology of the CAPSTONE® Spinal System has not been altered for this submission.

Identification of Legally Marketed Devices: The components contained in this CAPSTONE® Spinal System application are identical to those cleared in K121760 (SE 08/29/12), K120368 (SE 04/09/12), K103731 (SE 07/18/11) and K082732 (SE 10/16/08).

Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing: Published retrospective clinical data for the CAPSTONE® Spinal System as well as devices similar to the subject spinal system were provided in support of this application. This clinical data demonstrated that the use of interbody cages to treat deformity conditions posed no new risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.

Conclusion: The design features, materials used, manufacturing and sterilization methods are equivalent to the previously cleared CAPSTONE® Spinal System components with the exception of broadening a portion of the indications to include the aforementioned deformity conditions.

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

July 25, 2013

Medtronic Sofamor Danek, Incorporated % Mr. Lee Grant Senior Principal, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

Re: K123027

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: May 14, 2013 Received: May 15, 2013

Dear Mr. Grant:

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 - Mr. Lee Grant

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/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Erin詞《eith

For

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

Enclosure

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K123027 510(k) Number (if known):

Device Name: CAPSTONE® Spinal System

### Indications for Use:

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 SI. 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 nonoperative treatment.

Additionally, the CAPSTONE® Spinal System is indicated to assist 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.

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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices