# K122871: Compressyn Staple

- Pathway: 510(k) (Traditional)
- Applicant: Dallen Medical, Inc.
- Decided: Feb 7, 2013 after 141 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
Longest line of descent: 2 generations back to K902307 (1990). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043059: Compression Staple and Simple Staple, Wrightmedicaltechnologyinc (2005) Summary page 1.
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 1.
- K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System, Biomedical Ent., Inc. (2001)
- K840566: Bone Stapling Fixation Sys, 3M Company (1984) Summary page 1.

## Most influential descendants
- K132875: Compressyn Staple (2013), 3 descendants of its own
- K140358: Compressyn Staple (2014), 2 descendants of its own
- K172205: ExoToe Staple (2018), 0 descendants of its own
- K171473: Compressyn™ Staple (2017), 0 descendants of its own

## Indications for use
The Compressynm Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity;, the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.

Source page: https://510kreport.com/device/K122871
Methodology: https://510kreport.com/methodology