# K994207: Howmedica Osteonics Modular Rotating Hinge Knee

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 13, 2000 after 90 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- 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 K811630 (1981). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811630: Kinematic Rotating Hinge Total Knee PR., Howmedica Corp. (1981) Summary page 1.
- K932070: Duracon Stabilizer Femoral Component and Insert, Howmedica Corp. (1995) Summary page 1.
- K910500: Howmedica Kinemax Plus Total Knee System, Howmedica Corp. (1991) Summary page 1.

## Most influential descendants
- 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
- K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (2026), 0 descendants of its own

## Indications for use
The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions: ® There is destruction of the joint surfaces, with or without significant bone deformity. ® The cruciate and/or collateral ligaments do not stabilize the knee joint. ® The ligaments are inadequate and/or the musculature is weak. ® Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

Source page: https://510kreport.com/device/K994207
Methodology: https://510kreport.com/methodology