(169 days)
Not Found
No
The summary describes a purely mechanical implant for cervical fusion and makes no mention of AI or ML.
No
The device is described as an implant used in cervical fusion procedures to maintain the relative position of weak bony tissue, not to treat or cure a disease or condition. Its function is to provide physical support for grafts.
No
The device, C-JAWS Cervical Compressive Mini Frame, is described as an implant used in cervical fusion procedures to maintain the relative position of weak bony tissue. It is a single component system for anterior cervical anchoring, an implant made from CP titanium, and is not intended for load-bearing applications. Its function is to provide structural support during fusion, not to diagnose medical conditions by detecting, monitoring, or analyzing physiological parameters.
No
The device description clearly describes a physical implant made of CP titanium, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use in cervical fusion procedures to maintain the position of bony tissue. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a physical implant (a staple) made of titanium, designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KWQ, KWP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biomechanical testing, including pull out fixation tests were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
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.(b)
Classification. Class II.
0
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 | |
| 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
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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 (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
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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