# K061385: Osstaple, Ossplate, Ossforce

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Enterprises, Inc.
- Decided: May 30, 2007 after 377 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- 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: 3 generations back to K010911 (2001). 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)
- K062181: C-Jaws Cervical Compressive Mini Frame, Medicrea Technologies (2007). Cleared while this submission was under review Summary page 2.
- K021039: Bowti Anterior Buttress Staple System, Depuyacromed (2002) Summary page 2.

## Most influential descendants
- K073500: Active Anterior Cervical Plate System (2008), 0 descendants of its own

## Indications for use
For use in conjunction with traditional rigid fixation in cervical fusion procedures as a means to maintain the relative position of bony tissue such as allografts or autografts. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device. This device is not intended to be used alone for load bearing applications.

Source page: https://510kreport.com/device/K061385
Methodology: https://510kreport.com/methodology