# K240461: OsteoSinter® EVANS and COTTON wedges and related accessories

- Pathway: 510(k) (Abbreviated)
- Applicant: Ames Medical Prosthetic Solutions, S.A.U.
- Decided: Dec 6, 2024 after 294 days
- Product code: PLF (Bone Wedge)
- 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: 12 generations back to K810258 (1981). 86 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142724: BIOFOAM Bone Wedge, Wrightmedicaltechnologyinc (2015) Summary page 5.
- K151256: Arthrex BioSync® Bone Wedge, Arthex, Inc. (2015) Summary page 5.

## Most influential descendants
- K252254: Osteotomy Wedge System (2025), 0 descendants of its own
- K251791: Auxano® Wedge Fixation System (2025), 0 descendants of its own

## Indications for use
OsteoSinter® EVANS and COTTON wedges are intended to be used for internal bone fixation of bone fractures, fusions, or osteotomies in the foot. Specific Indications include: * Opening wedge osteotomies of the bones of the foot (including osteotomies for Hallux Valgus). * Opening wedge of Medial Cuneiform or Cotton osteotomies. * Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy). * Metatarsal/Cuneiform arthrodesis. OsteoSinter® EVANS and COTTON wedges are indicated for use with ancillary bone fixation. OsteoSinter® EVANS and COTTON wedges are not indicated for use in the spine

Source page: https://510kreport.com/device/K240461
Methodology: https://510kreport.com/methodology