C-JAWS Cervical Compressive Staple
510(k) K133906
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133906 | Date24 Jul 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PHQ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The C-JAWS Cervical Compressive Staple is an Anterior Staple as Supplemental Fixation for Fusion (OpenFDA classification: PHQ), designed for anterior cervical intervertebral body fixation. It features two ridged extension legs that engage vertebral bodies to provide secure anchorage, paired with a locking mechanism to prevent back-out during spinal stabilization procedures. This device is intended for use in one-level anterior cervical fusion surgeries as part of a supplemental fixation system.
The C-JAWS Staple is implanted in the operating room by surgeons during anterior cervical fusion procedures. It is supplied as a single-use device and is classified under FDA’s Class II regulatory framework, with FDA 510(k) clearance (K133906) under the Orthopedic advisory committee. No additional sterility or MRI safety information is specified in the regulatory data. The device is available in multiple registration numbers (e.g., 3025603301, 3033509898) as listed in the OpenFDA database.
Other devices from Medicrea International SA
Questions
AI-generated answers, 18 Sep 2026
What is the C-JAWS Cervical Compressive Staple specifically used for in spinal surgery?
The C-JAWS Cervical Compressive Staple is designed as an anterior staple for supplemental fixation in one-level anterior cervical fusion surgeries. It provides additional stabilization by engaging vertebral bodies with ridged extension legs and a locking mechanism to prevent back-out during spinal stabilization procedures. It is not intended as a standalone fixation device but rather as part of a broader fusion system.
Is the C-JAWS Staple reusable or single-use, and how should it be handled post-sterilization?
The C-JAWS Cervical Compressive Staple is explicitly labeled as a single-use device. While the regulatory data does not specify sterilization methods, standard practice for single-use orthopedic implants—such as ethylene oxide or gamma irradiation—would apply. It should not be reused or reprocessed after a single surgical procedure.
What sizes or models of the C-JAWS Staple are available, and how are they differentiated?
The C-JAWS Staple is available in multiple registration numbers (e.g., 3025603301, 3033509898, etc.), which likely correspond to variations in size, length, or other specifications. These differences are not detailed in the provided data, but the registration numbers can be cross-referenced with the manufacturer’s catalog or OpenFDA’s database for exact dimensions or model distinctions. No specific measurements (e.g., staple length, width) are provided in the regulatory submission.
How is the C-JAWS Staple supplied to the operating room, and what should clinicians expect in the packaging?
The C-JAWS Staple is supplied as a sterile, single-use device ready for immediate surgical use. While the packaging specifics (e.g., tray composition, sterilization indicators) are not detailed in the data, it would typically include the staple itself, any required instruments for implantation, and sterile packaging to maintain integrity until use. Clinicians should confirm with the manufacturer for exact packaging contents and handling instructions.
What regulatory pathway was followed for FDA clearance of the C-JAWS Staple, and which advisory committee reviewed it?
The C-JAWS Cervical Compressive Staple received FDA 510(k) clearance (K133906) under the Orthopedic (OR) Advisory Committee, classified as Substantially Equivalent (SESE) to a predicate device. The clearance was granted via a traditional review pathway and falls under FDA’s Class II regulatory framework for orthopedic staples. The decision was finalized on July 24, 2014, following submission on December 23, 2013.