CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER

K091531 · Choice Spine, Llp · ODP · Nov 2, 2009 · Orthopedic

Device Facts

• Record ID: K091531
• Device Name: CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER
• Applicant: Choice Spine, Llp
• Product Code: ODP · Orthopedic
• Decision Date: Nov 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.

Device Story

Choice Spine Cervical Interbody Spacer System consists of oval-shaped PEEK spacers with hollow centers for bone graft placement. Superior and inferior surfaces feature angled ridges (teeth) to resist migration. Available in various heights and lordotic angles to match patient anatomy. Used by surgeons in anterior cervical spine procedures to facilitate fusion at one level. Device acts as a structural support for autograft; requires supplemental fixation. Benefits include stabilization of the intervertebral space to promote fusion in patients with degenerative disc disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: PEEK-OPTIMA polymer (ASTM F2026) and tantalum radiopaque markers (ASTM F560). Design: Oval-shaped spacer with hollow center and angled surface ridges. Energy source: None (passive implant).

Indications for Use

Indicated for anterior cervical intervertebral body fusion at one level (C2-T1) in skeletally mature patients with degenerative disc disease (DDD) who failed 6 weeks of non-operative treatment. DDD defined as discogenic neck pain confirmed by history and radiography. Must be used with supplemental fixation and autograft.

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.

Submission Summary (Full Text)

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## 510(k) Summary

### Sponsor:

NOV. 2 2009

Choice Spine, LP 306 Erin Drive Knoxville, TN 37919 ph: 865.246.3333 x4 fax: [phone]

#### Contact:

G. Todd Hawkins Director of Regulatory Affairs/Quality Assurance

### Trade Name:

Choice Spine Cervical Interbody Spacer System

### Common Name:

Intervertebral body (or interbody) fusion device

### Classification & Name:

888.3080 - Intervertebral Fusion Device with Bone Graft, Cervical

# Device Product Code:

ODP

### Device Description:

The Choice Spine Cervical Interbody Spacer System implants ("spacers") have a basic oval shape with a hollow center for placement of bone graft. The superior and inferior surfaces have angled ridges, or "teeth," for resisting migration. The spacers are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.

#### Intended Use:

The Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.

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K091531

# 510(k) Summary (continued)

### Materials:

The Choice Spine Cervical Interbody Spacers are manufactured from polyetheretherketone (PEEK-OPTIMA polymer from Invibio ) as described by ASTM F2026. Integral radiopaque markers are manufactured from tantalum as described by ASTM F560.

### Substantial Equivalence:

Documentation was provided that demonstrates the Choice Spine Cervical Interbody Spacer System to be substantially equivalent to previously cleared device systems. The substantial equivalence is based upon equivalence in intended use, indications, anatomic location, material, method of stabilization, and performance.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or other bird-like figure with outstretched wings. The bird is depicted in a simple, abstract manner, with flowing lines suggesting movement and flight.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Choice Spine, LP % Mr. G. Todd Hawkins Director of Regulatory Affairs/QA 306 Erin Drive Knoxville, Tennessee 37919

# NOV ~ 2 2009

Re: K091531

Trade/Device Name: Choice Spine Cervical Interbody Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 27, 2009 Received: October 28, 2009

Dear Mr. Hawkins:

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.

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. G. Todd Hawkins

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milken

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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### Indications for Use

510(k) Number (if known): KO9 IS3 |

Device Name: Choice Spine Cervical Interbody Spacer System

Indications for Use:

The Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Millhiser

Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K09153

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