# K011219: Ascent Knee System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: May 18, 2001 after 28 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
No predicates in its family tree.
60 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K072785: Twinfix FT PK (2007), 59 descendants of its own
- K110545: Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) (2011), 40 descendants of its own
- K133671: Iconix All Suture Anchors (2014), 25 descendants of its own
- K093228: Smith & Nephew Twinfix Ultra PK Suture Anchor (2009), 19 descendants of its own
- K100159: Smith and Nephew Twinfix Ultra TI Suture Anchor (2010), 17 descendants of its own

Source page: https://510kreport.com/device/K011219
Methodology: https://510kreport.com/methodology
