# K011451: Reunite Fusion Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 10, 2001 after 213 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K850631 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953194: Lactosorb Bone Pin, Biomet, Inc. (1995) Summary page 1.
- K990291: Lactosorb Bone Pin, Biomet, Inc. (1999) Summary page 1.
- K992301: Reunite Screws, Biomet Manufacturing, Inc. (1999) Summary page 1.
- K901456: Orthosorb (R) Absorbable Pin, Johnson & Johnson International (1990) Summary page 1.
- K850631: Kirschner Orthopedic Wire, Eyelet Cerclage Wires, Kirschner Medical Corp. (1985) Summary page 1.

## Indications for use
The ReUnite Tm Fusion Screw is indicated for proximal interphalangeal (PIP) joint arthrodesis and distal interphalangeal (DIP) joint arthrodesis in the presence of appropriate protection or immobilization.

Source page: https://510kreport.com/device/K011451
Methodology: https://510kreport.com/methodology