# K023488: Osstaple, Craniofacial

- Pathway: 510(k) (Special)
- Applicant: Biomedical Enterprises, Inc.
- Decided: Oct 31, 2002 after 14 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 2.
- K001219: Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple  System, Biomedical Ent., Inc. (2000)
- K001353: Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System, Biomedical Ent., Inc. (2001)
- K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System, Biomedical Ent., Inc. (2001)

## Indications for use
Indications for the OSStaple'" are fixation of unloaded craniofacial bone fractures and cranioplasty. The OSStaple"' is contraindicated for craniofacial patients with a skull thickness less than the selected prong length.

Source page: https://510kreport.com/device/K023488
Methodology: https://510kreport.com/methodology