C-JAWS CERVICAL COMPRESSIVE MINI FRAME

K062181 · Medicrea Technologies · KWP · Jan 16, 2007 · Orthopedic

Device Facts

• Record ID: K062181
• Device Name: C-JAWS CERVICAL COMPRESSIVE MINI FRAME
• Applicant: Medicrea Technologies
• Product Code: KWP · Orthopedic
• Decision Date: Jan 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The C-JAWS Cervical Compressive Mini Frame, in conjunction with traditional rigid fixation, is intended for use in cervical fusion procedures as a means to maintain the relative position of weak bony tissue such as allograft or auto grafts. This device is not intended for load bearing applications.

Device Story

C-JAWS Cervical Compressive Mini Frame is a single-component anterior cervical anchoring staple; used in cervical fusion procedures to maintain position of bone grafts (allograft/autograft); functions as an adjunct to traditional rigid fixation; not for load-bearing. Implant features notched arms that engage vertebral bodies; mechanism involves plastic deformation of the implant body to conform to anterior cervical anatomy. Available in four sizes (15mm/20mm height; 14mm/17mm arm length). Manufactured from CP titanium. Used by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Biomechanical testing, including pull-out fixation tests, was conducted to evaluate performance.

Technological Characteristics

Material: CP titanium. Design: Single-component staple with notched arms. Mechanism: Plastic deformation of the implant body for anatomical conformity. Dimensions: Four sizes (15mm/20mm height; 14mm/17mm arm length). Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use in cervical fusion procedures to maintain the relative position of weak bony tissue (allograft or autograft) in conjunction with traditional rigid fixation. Not for load-bearing applications.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (K021039)
• MACROPORE OS SPINAL SYSTEM (K010911)

Submission Summary (Full Text)

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510 (k) Premarket Notification

Carlos

JAN 16 2007

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# 510(k) SUMMARY of Safety and Effectiveness

| Trade Name | C-JAWS Cervical Compressive Mini Frame |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name | Anterior Cervical Buttress Staple System |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | KWQ |
| CFR section | 888. 3060 |
| Device panel | Orthopedic |
| Legally marketed predicate<br>devices | BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (K021039)<br>MACROPORE OS SPINAL SYSTEM (K010911) |
| Submitter | MEDICREA TECHNOLOGIES<br>ZI Chef de Baie<br>17000 La Rochelle<br>France |
| Contact | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>Phone [phone]<br>email : ortho [e-mail] |

## 1. GENERAL INFORMATION

#### 2. DEVICE DESCRIPTION

The C-JAWS implant is a single component system of anterior cervical anchoring. The staple is uniquely shaped to conform to the anatomy of the anterior of from and one notched arms, which engage the vertebral bodies and works by plastic deformation of the implants body. The staples are available in four sizes, 15mm and 20mm for the height, 14 and 17mm for the arms length. The C-JAWS implant is manufactured from CP titanium and has a smooth and dirinh.

#### 3. INTENDED USE

The C-JAWS implant, in conjunction with traditional rigid fixation, is intended for use in cervical fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

### 4. PERFORMANCE DATA

Biomechanical testing, including pull out fixation tests were conducted.

### 5. SUBSTANTIAL EQUIVALENCE

The C-JAWS Cervical Compressive Mini Frame is substantially equivalent to the BOWTI anterior buttress staple system (Depuy Acromed -- K021039) and MacroPore OS Spinal System (MacroPore, Inc. - K010911).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicrea Technologies % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

JAN 16 2007

Re: K062181

Trade/Device Name: C-JAWS Cervical Compressive Mini Frame Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: January 3, 2007 Received: January 8, 2007

Dear Mr. Webb:

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 such 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); good manufacturing practice requirements as set 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.

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Page 2 - Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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.

Harbaya Buelum
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Premarket Notification

다. 서비스 등

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# INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: C-JAWS Cervical compressive mini frame Indications for Use:

The C-JAWS Cervical Compressive Mini Frame, in conjunction with traditional rigid fixation, is intended for use in cervical fusion procedures as a means to maintain the relative position of weak bony tissue such as allograft or auto grafts. This device is not intended for load bearing applications.

Prescription Use > (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Abarbanel Muchin

Division of General, Restorative, and Neurological Devices

510(k) Number K062181