# K082231: Ascension Silicone Pip

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Jan 12, 2009 after 158 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 K970544 (1997). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 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 1.
- K001922: Depuy Neuflex Pip Finger, Depuy, Inc. (2000) Summary page 1.

## Most influential descendants
- K233670: Ascension Silicone MCP; Ascension Silicone PIP (2023), 0 descendants of its own
- K220142: BRM Digitalis Spacer (2023), 0 descendants of its own

## Recalls of this device
- Nov 4, 2019 · Class II · Z-0691-2020: Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant

## Indications for use
The indications for use of the Ascension Silicone PIP are for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

Source page: https://510kreport.com/device/K082231
Methodology: https://510kreport.com/methodology