# K811630: Kinematic Rotating Hinge Total Knee PR.

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jul 1, 1981 after 22 days
- Product code: LGE (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 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
- K994207: Howmedica Osteonics Modular Rotating Hinge Knee (2000), 6 descendants of its own
- K223069: Modular Rotating Hinge Knee Systems and Compatible Components (2023), 4 descendants of its own
- K223528: Triathlon® Hinge Knee System (2023), 4 descendants of its own
- K230416: Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (2023), 3 descendants of its own
- K251665: Triathlon® Hinge Knee System (2025), 2 descendants of its own

Source page: https://510kreport.com/device/K811630
Methodology: https://510kreport.com/methodology