# K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Ent., Inc.
- Decided: Mar 13, 2001 after 319 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.
28 later devices descend from it; 7 cite it directly.
0 of 29 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
- K142292: Speed, Speed Shift, Speed Titan, Speed Arc (2014), 13 descendants of its own
- K122871: Compressyn Staple (2013), 4 descendants of its own
- K193305: DynaClip Bone Staple (2020), 3 descendants of its own
- K170923: JAWS (TM) Nitinol Staple System (2017), 3 descendants of its own
- K132875: Compressyn Staple (2013), 3 descendants of its own

Source page: https://510kreport.com/device/K001354
Methodology: https://510kreport.com/methodology