(9 days)
K/DEN: Not Found
No
The description focuses on the mechanical properties and dimensions of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a non-load-bearing implant intended to maintain the relative position of weak bony tissue in cervical fusion procedures, which classifies it as a surgical instrument or implant rather than a therapeutic device in a broader sense that would imply active treatment of a disease or condition.
No
The device is described as an implant used in cervical fusion procedures to maintain the position of bony tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an implant manufactured from CP titanium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / 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.
Product codes
KWQ
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 spine. It features two notched arms, which engage the vertebral bodies and works by plastic deformation of the implant's body. The staples are available in multiple sizes the C-JAWS implant is manufactured from CP titanium and has a smooth anodized finish.
The purpose of this submission is to add additional sizes to the C-JAWS implant range: height of 12.5, 17.5 and 22.5mm and arm lengths of 10, 12, 14 and 17mm. In addition, radii (R=0.2mm) have been added to the extremity of both legs to reduce the sharpness of the tips of the C-JAWS legs. The modification is effective on the new submitted C-JAWS implants and has been applied to the K062181 cleared implants. Additional instruments are also added.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
AUG 2 3 2007
Image /page/0/Picture/1 description: The image shows the number K072040 written in black ink. The number is written in a handwritten style. Below the number is a black rectangle with some text inside, but the text is not clear enough to read.
SPECIAL 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
GENERAL INFORMATION 1.
| 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 | C-JAWS CERVICAL COMPRESSIVE MINI FRAME (K062181) |
| 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 |
2. PREDICATE 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 spine. It features two notched arms, which engage the vertebral bodies and works by plastic deformation of the implant's body. The staples are available in multiple sizes the C-JAWS implant is manufactured from CP titanium and has a smooth anodized finish.
3. DESCRIPTION OF DEVICE MODIFICATION
The purpose of this submission is to add additional sizes to the C-JAWS implant range: height of 12.5, 17.5 and 22.5mm and arm lengths of 10, 12, 14 and 17mm.
1
Image /page/1/Picture/0 description: The image is a rectangular sign with a black background and a white border. On the left side of the sign, there is a white star shape with some text below it. The rest of the sign is filled with black, with some white text or symbols scattered throughout. The sign appears to be a label or a marker of some kind.
In addition, radii (R=0.2mm) have been added to the extremity of both legs to reduce the sharpness of the tips of the C-JAWS legs. The modification is effective on the new submitted C-JAWS implants and has been applied to the K062181 cleared implants.
Additional instruments are also added.
INTENDED USE 4.
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.
5. PERFORMANCE DATA
Biomechanical testing, including pull out fixation tests were conducted.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2007
Medicrea Technologies % The OrthoMedix Group Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, Texas 78681
Re: K072040
Trade/Device Name: C-JAWS Cervical Compression Mini Frame Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: July 16, 2007 Received: July 25, 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.
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbave Buchud
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MEDICREA™
INDICATIONS FOR USE
510(k) Number (if known): K072040
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)
Barbara Buchner for mem
(Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number K072040