# K021559: Ascent All-Poly PS Tibial Bearings

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jun 5, 2002 after 23 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- 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 K934589 (1994). 1 ancestor in all.
16 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934589: Kirschner Performance Total Knee System Porous Coated, Kirschner Medical Corp. (1994) Summary page 1.

## Most influential descendants
- K082019: Freedom Total Knee System (2009), 15 descendants of its own
- K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component (2009), 7 descendants of its own
- K131481: Freedom PCK Components (2014), 6 descendants of its own
- K160771: Destiknee Total Knee System (2016), 3 descendants of its own
- K200912: Freedom (R) - TiNbN Coated Knee (2020), 2 descendants of its own

## Indications for use
The AscentTMAll-Poly PS Tibial Bearings are for the painful and disabled knee joint resulting form osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is for use with bone cement.

Source page: https://510kreport.com/device/K021559
Methodology: https://510kreport.com/methodology