# K060360: Howmedica Osteonics Modular Rotating Hinge Knee with Offset Adapters

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 15, 2006 after 30 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Howmedica Osteonics Modular Rotating Hinge Knee: named in the summary without a submission number
- (no number) Howmedica Total Stabilizer Knee Components: named in the summary without a submission number

## 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/K060360
Methodology: https://510kreport.com/methodology