# K233670: Ascension Silicone MCP; Ascension Silicone PIP

- Pathway: 510(k) (Special)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Dec 14, 2023 after 29 days
- Product code: KYJ (Prosthesis, Finger, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970544 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022892: Ascension Sillicone MCP, Ascension Orthopedics, Inc. (2002) Summary page 4.
- K082231: Ascension Silicone Pip, Ascension Orthopedics, Inc. (2009) Summary page 4.

## Indications for use
The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis. The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

Source page: https://510kreport.com/device/K233670
Methodology: https://510kreport.com/methodology