# K140453: Osteotec Silicone Finger Implant

- Pathway: 510(k) (Traditional)
- Applicant: Osteotec, Ltd.
- Decided: Apr 17, 2015 after 417 days
- Product code: KYJ (Prosthesis, Finger, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3230
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K870200 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013629: Finger Joint Prosthesis, Avanta Orthopaedics, Inc. (2002) Summary page 5.
- (no number) Swanson Flexible Finger Joint Implant: named in the summary without a submission number

## Recalls of this device
- Jun 18, 2025 · Class II · Z-2222-2025: There is the potential that the silicone implant may contain foreign material

## Indications for use
The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis.

Source page: https://510kreport.com/device/K140453
Methodology: https://510kreport.com/methodology