CLYDESDALE(R) SPINAL SYSTEM

K133577 · Medtronic Sofamor Danek USA, Inc. · MAX · Sep 26, 2014 · Orthopedic

Device Facts

• Record ID: K133577
• Device Name: CLYDESDALE(R) SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Sep 26, 2014
• 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
K133577 · Sep 26, 2014	CLYDESDALE(R) SPINAL SYSTEM	Medtronic Sofamor Danek USA, Inc.	Published retrospective clinical literature	The sponsor provided 14 retrospective clinical articles (8 regarding the subject device and 6 regarding the predicate device) to demonstrate clinical performance and safety for the expanded indication of adult degenerative scoliosis. The data showed improvements in pain scores (VAS, ODI, Treatment Intensity Score) and deformity correction comparable to the predicate.	Retrospective clinical data; Adult degenerative scoliosis; Pain score improvement; Deformity correction

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Literature review of retrospective clinical data; Retrospective clinical study/case series	Patients with adult degenerative scoliosis	CAPSTONE® Spinal System	Pain score measurements (VAS, ODI, Treatment Intensity Score) and deformity correction

Indications for Use

The CLYDESDALE® 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 CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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. Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.

Device Story

System consists of PEEK interbody cages; inserted between lumbar/lumbosacral vertebral bodies; hollow geometry allows packing with autogenous bone graft; provides support/correction during fusion. Used in OR by surgeons via minimally invasive lateral approach. Acts as construct anchor in degenerative scoliosis cases to restore sagittal/coronal balance. Supplements pedicle screw fixation systems. Benefits include stabilization of spinal segments and deformity correction. Output is physical structural support; surgeon assesses placement via radiographic imaging.

Clinical Evidence

Retrospective clinical data provided via 14 published articles. Eight articles evaluated CLYDESDALE® and six evaluated the predicate CAPSTONE® in adult degenerative scoliosis cases. Results showed comparable improvements in pain scores (Visual Analogue Scale, Oswestry Disability Index, Treatment Intensity Score) and deformity correction between the subject and predicate devices. No new bench testing performed as device design remains unchanged.

Technological Characteristics

Implants are convex, bullet-nosed cages made of PEEK. Designed for interbody fusion and anterior column support. System is used with supplemental pedicle screw fixation. No changes to materials, design, or sterilization methods from previously cleared versions.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels (L2-S1), including those with Grade I Spondylolisthesis or retrolisthesis, who have failed six months of nonoperative treatment. Also indicated for anterior column support in patients with degenerative scoliosis as an adjunct to pedicle screw fixation.

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 (K123027)

Reference Devices

• CLYDESDALE® Spinal System (K132897)
• CLYDESDALE® Spinal System (K122591)
• CLYDESDALE® Spinal System (K113528)
• CLYDESDALE® Spinal System (K112405)
• CLYDESDALE® Spinal System (K100175)
• CLYDESDALE® Spinal System (K083026)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. The profiles are simple and abstract, with a flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

September 26, 2014

Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132

Re: K133577

Trade/Device Name: CLYDESDALE® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 20, 2014 Received: August 21, 2014

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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Ronald#Alean -S for

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

Enclosure

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# Indications for Use

510(k) Number (if known) K133577

#### Device Name CLYDESDALE® Spinal System

#### Indications for Use (Describe)

The CLYDESDALE® 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 CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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. Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.

| Type of Use (Select one or both, as applicable) | |
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# CLYDESDALE® Spinal System 510(k) Summary - K133577

September 2014

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

### Proposed Proprietary Trade Name: CLYDESDALE® Spinal System

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

Description: The CLYDESDALE® 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. When used to supplement pedicle screw fixation systems in adult degenerative scoliosis cases, the CLYDESDALE® device is used as a construct anchor and to help restore sagittal and coronal balance.

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

Indications for Use: The CLYDESDALE® 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 CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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. Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.

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Summary of the Technological Characteristics: The CLYDESDALE® Spinal System implants contained in this application are identical to those previously cleared in earlier 510(k) applications. The CLYDESDALE® Spinal System remains comprised of convex. bullet-nosed interbody devices intended to facilitate a fusion between two vertebral bodies. The fundamental scientific technology of the CLYDESDALE® Spinal System has not been altered for this submission.

Identification of Legally Marketed Devices: The CLYDESDALE® Spinal System is similar in design to the CAPSTONE®) Spinal System which was cleared for the requested indication in K123027 (SE 07/25/13), the primary predicate. The components contained in this application are identical to those cleared in previous CLYDESDALE® Spinal System applications including K132897 (SE 03/13/14) K122591 (SE 09/18/12), K113528 (SE 12/20/11), K112405 (SE 11/21/11), K100175 (SE 06/02/10), and K083026 (SE 12/29/08). No new implants are included in this application.

Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing: Published retrospective clinical data for the CLYDESDALE® Spinal System as well as devices similar to the subject spinal system were provided in support of this application. Eight articles specifically referenced CLYDESDALE® Spinal System interbody cages as the implants used in adult degenerative scoliosis cases, while another six articles referenced the primary predicate device (CAPSTONE® Spinal System) as the interbody cage used in similar procedures. All of the CLYDESDALE® patients were treated via a minimally invasive lateral approach. Fusion results were not provided in all papers, but improvement in various pain score measurements (Visual Analogue Scale, Oswestry Disability Index, and Treatment Intensity Score) were comparable to those reported in the literature for similar patients treated with CAPSTONE® Spinal System interbody devices used with posterior fixation. Comparable improvements in deformity correction were also reported in 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 CLYDESDALE® Spinal System components with the exception of broadening a portion of the indications to include the aforementioned deformity condition of adult degenerative scoliosis.