← Product Code [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP) · K062181 # C-JAWS CERVICAL COMPRESSIVE MINI FRAME (K062181) _Medicrea Technologies · KWP · Jan 16, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K062181 ## Device Facts - **Applicant:** Medicrea Technologies - **Product Code:** [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP.md) - **Decision Date:** Jan 16, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3050 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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](/device/K021039.md)) - MACROPORE OS SPINAL SYSTEM ([K010911](/device/K010911.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 510 (k) Premarket Notification Carlos JAN 16 2007 Image /page/0/Picture/3 description: The image shows the logo for "Mediatek Technologies". The logo is in black and white, with the word "Mediatek" in large, bold letters. Below the word "Mediatek" is the word "Technologies" in smaller letters. The logo is simple and modern. # 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
devices | BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (K021039)
MACROPORE OS SPINAL SYSTEM (K010911) | | Submitter | MEDICREA TECHNOLOGIES
ZI Chef de Baie
17000 La Rochelle
France | | Contact | J.D. Webb
1001 Oakwood Blvd
Round Rock, TX 78681
Phone 512-388-0199
email : ortho medix@sbcglobal.net | ## 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). {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/12 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 image of an eagle or bird-like figure, with three curved lines representing its wings or body. The logo is black and white. 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. {2}------------------------------------------------ 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 {3}------------------------------------------------ 510 (k) Premarket Notification 다. 서비스 등 Image /page/3/Picture/2 description: The image shows the logo for "MEDIARADIX TECHNOLOGIES". The logo is in black and white, with the word "MEDIARADIX" in large, bold letters. Below that, in smaller letters, is the word "TECHNOLOGIES". The background of the logo is a textured gray. Page 1 of 1 # 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K062181](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K062181) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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