# K894929: Staple Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Concept, Inc.
- Decided: Aug 30, 1989 after 28 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962705: Mli Modular Staple (1996), 25 descendants of its own
- K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple (2012), 24 descendants of its own
- K131061: Restore Bunion Correction System (2013), 15 descendants of its own
- K170214: Additive Orthopaedics Locking Lattice Plate (2017), 8 descendants of its own
- K222645: Treace Medical Concepts (TMC) Implant Fixation System (2022), 6 descendants of its own

Source page: https://510kreport.com/device/K894929
Methodology: https://510kreport.com/methodology