# K133906: C-Jaws Cervical Compressive Staple

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International
- Decided: Jul 24, 2014 after 213 days
- Product code: PHQ (Anterior Staple As Supplemental Fixation For Fusion)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914362 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 1.
- K792352: Synthes Cervical Vertabrae Plates, DePuy Synthes (1979) Summary page 1.

## Most influential descendants
- K200301: UNiTi ACDF Implant System (2021), 0 descendants of its own

## 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 myclopathy 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.

Source page: https://510kreport.com/device/K133906
Methodology: https://510kreport.com/methodology