ANATOMIC PEEK CERVICAL FUSION SYSTEM

K130177 · Medtronic Sofamor Danek USA, Inc. · ODP · Sep 23, 2013 · Orthopedic

Device Facts

• Record ID: K130177
• Device Name: ANATOMIC PEEK CERVICAL FUSION SYSTEM
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Sep 23, 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
K130177 · Sep 23, 2013	ANATOMIC PEEK CERVICAL FUSION SYSTEM	Medtronic Sofamor Danek USA, Inc.	Published retrospective clinical literature	The sponsor provided published retrospective clinical data for similar cervical interbody fusion devices to demonstrate that the use of allogenic bone graft in anterior cervical interbody fusion procedures poses no new risks.	Retrospective clinical data; Literature review; Allogenic bone graft; Cervical fusion

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Published retrospective clinical data for cervical interbody fusion devices; Retrospective clinical study/literature review	Patients diagnosed with cervical disc disease	Not applicable for this study	Safety and clinical outcomes of allogenic bone graft use in anterior cervical interbody fusion

Indications for Use

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK™ device is to be used with supplemental fixation. The ANA TOMIC PEEK™ CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.

Device Story

Hemi-cylindrical PEEK OPTIMA™ cages; hollow geometry for packing with autogenous or allogenic bone graft; implanted via open anterior approach by surgeons; used for cervical interbody fusion; requires supplemental fixation; provides structural support to facilitate fusion in patients with cervical disc disease; no changes to implant design; submission expands graft material options to include allogenic bone.

Clinical Evidence

No new clinical trials performed. Evidence consists of published retrospective clinical data for similar cervical interbody fusion devices, supporting the use of allogenic cancellous and/or corticocancellous bone graft as an alternative to autogenous bone graft.

Technological Characteristics

Material: PEEK OPTIMA™. Form factor: Hemi-cylindrical cages of various widths, heights, and depths. Hollow geometry for bone graft containment. Implanted via open anterior approach. No software or energy source.

Indications for Use

Indicated for cervical interbody fusion in skeletally mature patients with cervical disc disease (intractable radiculopathy/myelopathy, herniated disc, or osteophyte formation with nerve root/spinal cord compression) at one level from C2-C3 to C7-T1. Requires six weeks of prior non-operative treatment. Must be used with supplemental fixation and autogenous or allogenic (cancellous/corticocancellous) bone graft via open anterior approach.

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

• ANATOMIC PEEK™ CERVICAL FUSION SYSTEM (K112444)

Submission Summary (Full Text)

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## Medtronic Sofamor Danek ANATOMIC PEEK™ CERVICAL FUSION SYSTEM 510(k) Summary - K130177

September 2013

Company:

Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: [phone] Fax: [phone]

2 3 2013

Contact:

### Lee Grant Distinguished Regulatory Affairs Advisor

Proposed Proprietary Trade Name: ANATOMIC PEEK™ CERVICAL FUSION SYSTEM

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

Description: The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from polyetheretherketone (PEEK OPTIMA™) and is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The ANATOMIC™ PEEK CERVICAL FUSION SYSTEM consists of hemi-cylindrical cages of various widths, heights and depths. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Indications for Use: The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK™ device is to be used with supplemental fixation. The ANA TOMIC PEEK™ CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.

Summary of the Technological Characteristics: The purpose of this 510(k) submission is to seek clearance for the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative to autogenous bone graft. No changes have been made to the actual implants.

Identification of Legally Marketed Devices: The components contained in this application are identical to those cleared in K112444 (SE 11/15/11) with the exception of

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the inclusion of allogenic cancellous and/or corticocancellous bone graft as an alternative bone graft material.

Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing: Published retrospective clinical data for the cervical interbody fusion devices similar to the ANATOMIC PEEK™ CERVICAL FUSION SYSTEM was provided in support of this application. The published clinical outcomes demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease as defined above poses 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 ANATOMIC PEEK™ CERVICAL FUSION SYSTEM components with the exception of broadening the indications to include the aforementioned use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative graft material.

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

September 23, 2013

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

Re: K130177

> Trade/Device Name: ANATOMIC PEEK™ Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: August 7, 2013 Received: August 14. 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. Iisting 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 mislcading.

ff your device is classified (see above) into cither 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Erin I. Keith

for

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

Enclosure

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September 2013

510(k) Number (if known): _ K130177

Device Name: ANATOMIC PEEK™ CERVICAL FUSION SYSTEM

#### Indications for Use:

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of nonoperative treatment. The ANATOMIC PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.

Prescription Use x (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