# K000978: Anatomic Total Knee Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 22, 2000 after 87 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.
64 later devices descend from it; 2 cite it directly.
0 of 65 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
- K052687: Conformis, Inc. Total Knee Repair System (2006), 43 descendants of its own
- K094050: Itotal CR Knee Replacement System (2010), 41 descendants of its own
- K103117: Itotal Cruciate Retaining (CR) Knee Replacement System (2011), 40 descendants of its own
- K112780: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System (2011), 38 descendants of its own
- K120316: Itotal Cruciate Retaining (CR) Knee Replacement System (2012), 36 descendants of its own

Source page: https://510kreport.com/device/K000978
Methodology: https://510kreport.com/methodology