# K122770: Biomet Reconstructive Wedges Model 110003660-99, 110003797-831

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 28, 2013 after 199 days
- Product code: HRS (Plate, 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: 1 generation back to K070592 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070592: Small Bone Wedge, Wrightmedicaltechnologyinc (2007) Summary page 1.
- K073535: Biofoam Bone Wedge, Wrightmedicaltechnologyinc (2008) Summary page 1.
- K093950: Biofoam Bone Wedge Model Assorted, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Indications for use
Biomet Reconstructive Wedges are intended to be used for internal bone fixation for bone structures, fusions or osteotomies in the ankle and foot, such as: * Open wedge osteotomies of Hallux Valgus * Evans lengthening osteotomies * Metatarsal/cuneiform arthrodesis Biomet Reconstructive Wedges are intended for use with ancillary fixation. Biomet Reconstructive Wedges are not intended for use in the spine.

Source page: https://510kreport.com/device/K122770
Methodology: https://510kreport.com/methodology