(213 days)
Not Found
No
The document describes a mechanical implant (staple) for spinal fusion and its associated instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical and clinical trials, not related to AI/ML model performance.
Yes.
The device is a medical implant used for anterior cervical intervertebral body fixation as part of a cervical fusion procedure to treat degenerative disc disease and associated neurological symptoms, which indicates a therapeutic purpose.
No
This device is a cervical compressive staple intended for anterior cervical intervertebral body fixation as part of a fusion procedure, making it a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "single component system" manufactured from CP Titanium and includes "Class I instruments and non-implantable devices manufactured from stainless steel," indicating it is a physical implant and associated hardware, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the C-JAWS cervical compressive staple is an implantable device intended for anterior cervical intervertebral body fixation as part of a fusion procedure. It is a physical device used to stabilize the spine.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples, perform tests, or provide diagnostic information about a patient's condition based on biological samples.
Therefore, the C-JAWS cervical compressive staple is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The C-JAWS cervical compressive staple is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.
Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myelopathy with herniated disc producing symptomatic nerve root and or spinal compression confirmed by radiographic studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.
The C-JAWS cervical compressive staple is limited to one level fusion. A single C-JAWS staple must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.
WARNING: The C-JAWS cervical compressive staple is not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
PHQ
Device Description
The C-JAWS cervical compressive staple device is a single component system. The device is shaped to conform to the anatomy of the anterior spine. It features two ridged extension legs, which engage the vertebral bodies and allow secure anchorage of the device and antiback-out using a locking mechanism.
Materials: The C-JAWS cervical compressive staple device is manufactured from CP Titanium (T40. ASTM F-67). The complete C-JAWS cervical compressive staple device contains Class I instruments and non-implantable devices manufactured from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 to C7
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)
Mechanical testing indicates that the C-JAWS cervical compressive staple device is capable of performing in accordance with its intended use. Testing was performed on the C-JAWS following the protocols outlined in ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model".
The following tests were conducted:
- Static Compression .
- . Static torsion
- . □Dynamic compression
The clinical safety and performance of the C-JAWS was established by clinical studies that involved 118 patients who underwent cervical fusion with the C-JAWS, an interbody fusion device, and autograft. Data from these studies demonstrate an overall fusion rate of 95.8% and a safety profile directly comparable to standard of care fusion using allograft and anterior cervical plate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
overall fusion rate of 95.8%
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
§ 888.3060 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.
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KI 33906 Page 1 of 3
JUL 2 4 2014
510(k) SUMMARY
Medicrea's C-JAWS Compressive Cervical Staple
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the C-JAWS.
Date Prepared: July 23, 2014
Submitter:
MEDICREA INTERNATIONAL 14 Porte du Grand Lyon NEYRON 01700 FRANCE
Contact Person:
Audrey VION Regulatory Affairs Manager MEDICREA INTERNATIONAL
Trade Name:
C-JAWS Cervical Compressive Staple
Common Name:
Anterior Cervical Stabilization Device
Classification Name:
Anterior staple as supplemental fixation for fusion
Product Code and Regulation:
PHQ, 21 C.F.R. 888.3060
Predicate Devices
Depuv Spine Uniplate Anterior Cervical Plate System (K042544)
Synthes Orozco Plate (K792352)
Intended Use / Indications for Use
The C-JAWS cervical compressive staple is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.
Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myelopathy with herniated disc producing symptomatic nerve root and or spinal compression confirmed by radiographic studies and/or with
1
osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.
The C-JAWS cervical compressive staple is limited to one level fusion. A single C-JAWS staple must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.
WARNING: The C-JAWS cervical compressive staple is not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Technological Characteristics
The C-JAWS cervical compressive staple device is a single component system. The device is shaped to conform to the anatomy of the anterior spine. It features two ridged extension legs, which engage the vertebral bodies and allow secure anchorage of the device and antiback-out using a locking mechanism.
Materials: The C-JAWS cervical compressive staple device is manufactured from CP Titanium (T40. ASTM F-67). The complete C-JAWS cervical compressive staple device contains Class I instruments and non-implantable devices manufactured from stainless steel.
Non-clinical Test Summary
Mechanical testing indicates that the C-JAWS cervical compressive staple device is capable of performing in accordance with its intended use. Testing was performed on the C-JAWS following the protocols outlined in ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model".
The following tests were conducted:
- Static Compression .
- . Static torsion
- . □Dynamic compression
Clinical Test Summary
The clinical safety and performance of the C-JAWS was established by clinical studies that involved 118 patients who underwent cervical fusion with the C-JAWS, an interbody fusion device, and autograft. Data from these studies demonstrate an overall fusion rate of 95.8% and a safety profile directly comparable to standard of care fusion using allograft and anterior cervical plate.
Substantial Equivalence
Based on the clinical performance data, the C-JAWS compressive staple has been shown to be as safe and effective, as compared to the predicate devices when used per the cleared indications. The C-JAWS has similar materials, technological characteristics and principles
2
:
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of operation as its predicate devices. Thus, the C-JAWS cervical compressive staple is substantially equivalent to the referenced predicate devices.
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:
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and the comments of the comments of
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2014
Medicrea International, Incorporated % John J. Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K133906
Trade/Device Name: C-JAWS Cervical Compressive Staple Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: PHO Dated: June 24, 2014 Received: June 24, 2014
Dear Dr. Smith:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
4
Page 2 -- John J. Smith, M.D., J.D.
forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133906
Device Name
C-JAWS Cervical Compressive Staple
Indications for Use (Describe)
The C-JAWS cervical compressive is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.
Indications are limited to patients with degenerative discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy with hemiated disc producing symptomatic nerve root and/or spinal compression studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.
The C-JA WS cervical compressive staple is limited to one level fusion. A single C-JA WS staple must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.
WARNING: The C-JAWS cervical compressive staple is not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Katherine D. Kavlock, PhD
Division of Orthopedic Devices
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