CRESCENT SPINAL SYSTEM

K133216 · Medtronic Sofamor Danek, Inc. · MAX · Nov 22, 2013 · Orthopedic

Device Facts

• Record ID: K133216
• Device Name: CRESCENT SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Nov 22, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous 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 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

CRESCENT® Spinal System consists of hollow, bullet-nosed, anatomically shaped intervertebral body spacers; designed to hold bone graft material. Implants feature diamond V teeth on superior/inferior surfaces for expulsion resistance. Used in lumbar spine via posterior, transforaminal, or lateral approach; procedure may be open or minimally invasive. Implants are manufactured from PEEK-Optima LTI with Tantalum markers for radiographic visualization. Device requires supplemental fixation instrumentation cleared for lumbar spine use. Intended to facilitate interbody fusion in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Engineering rationale and risk analysis provided to support the addition of a new implant size; no clinical data included.

Technological Characteristics

Materials: PEEK-Optima LTI (polyetheretherketone) and Tantalum markers. Design: Hollow, bullet-nosed, anatomically shaped spacer with diamond V teeth. Dimensions: 7mm-15mm height, 36mm length, 14.5mm width. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Includes patients with up to Grade 1 spondylolisthesis or retrolisthesis. Requires six months of prior 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

• CRESCENT™ Spinal System (K094025)
• CRESCENT® Spinal System Titanium (K110543)

Submission Summary (Full Text)

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# CRESCENT® Spinal System 510(k) Summary October 2013

NOV 22222013

I. COMPANY:

Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis, Tennessee 38132

II. CONTACT:

Ankit K. Shah Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]

CRESCENT® Spinal System

III. PROPRIETARY TRADE NAME:

IV. CLASSIFICATION NAMES:

COMMON NAME:

CLASS:

Intervertebral Fusion with Bone Graft. Lumbar

Intervertebral Body Fusion Device

CLASS:

II

MAX (21 CFR 888.3080)

# V. PRODUCT DESCRIPTION:

PRODUCT CODE:

The subject CRESCENT® Spinal System consists of a variety of hollow intervertebral body spacers featuring a bullet-nosed, anatomically shaped design with axial voids designed to hold bone graft material. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The subject devices are designed with diamond V teeth across both superior and inferior

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#### K133216

surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 7mm to 15mm in height and 36mm in length. The devices are manufactured from medical grade PEEK-Optima LTI (polyetheretherketone). These devices also contain Tantalum markers used for imaging purposes.

## VI. INDICATIONS FOR USE:

The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous 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 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 subject CRESCENT® Spinal System has the same indications, intended use and fundamental scientific technology as the previously FDA cleared predicates: CRESCENT™ Spinal System K094025 (S.E. 04/26/2010) and CRESCENT® Spinal System Titanium K110543 (S.E. 08/09/2011). The material of subject CRESCENT® Spinal System implant is identical to the predicate CRESCENT™ Spinal System (K094025). The purpose of this submission is to seek clearance for the additional sizes of PEEK implant being added to the CRESCENT® Spinal System.

# VIII. Identification of Legally Marketed Devices:

The fundamental scientific technology, design features and indications for use for the subject CRESCENT®Spinal System are identical to the predicate CRESCENT™ Spinal System K094025 (S.E. 04/26/2010) and CRESCENT® Spinal System Titanium K110543 (S.E. 08/09/2011).

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## IX. Discussion of Non-Clinical Testing:

The widths of the predicate CRESCENT™ Spinal System K094025 (PEEK implants) are 1 Imm, 12mm and 12.5mm. The subject CRESCENT® Spinal System is for introducing a 14.5mm wide PEEK implant. ASTM F2077 *Test Methods for Intervertebral Body Fusion Devices," defines a worst case intervertebral body fusion device with the smallest footprint and tallest height: Medtronic believes that since the footprint is not reducing, it does not introduce a worst case.

The 14.5mm wide Titanium implants are already cleared by the FDA in the predicate CRESCENT® Spinal System Titanium K110543.

Medtronic believes that the subject 14.5mm wide PEEK implant does not introduce a new worst case scenario, which has been documented in a confirmatory engineering rationale. Medtronic believes that the subject device is substantially equivalent to the predicate device.

## X. Conclusion:

An engineering rationale and risk analysis has been completed for the change. Based on the engineering rationale, risk analysis and additional supporting documentation provided in this premarket notification. Medtronic believes the subject system demonstrates substantial equivalence to listed predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 22, 2013

Medtronic Sofamor Danek USA, Incorporated Mr. Ankit K. Shah Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K133216

Trade/Device Name: CRESCENT® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 17, 2013 Received: October 18, 2013

Dear Mr. Shah:

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 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. Ankit K. Shah

:

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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" (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.html 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 yours,

Lori A. Wiggins

for

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

Enclosure

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K133216 510(k) Number (if known): _

Device Name: CRESCENT® Spinal System

## Indications for Use:

The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous 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 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

.