# K992346: Kinematic II Rotating Hinge Knee

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 12, 1999 after 30 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Kinematic II Rotating Hinge Knee Metal Tibial Bearing Component: named in the summary without a submission number
- (no number) Kinematic II Rotating Hinge Knee Tibial Plugs: named in the summary without a submission number

## Most influential descendants
- K142814: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (2015), 1 descendant of its own
- K253515: Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments (2026), 0 descendants of its own

## Indications for use
The intended use of the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components is identical to that of the Modular Replacement System. The Modular Replacement System was cleared via 510(k) #K952970. A second submission, reference 510(k) #K972401, was found substantially equivalent which expanded the indications for use for the system. The original indications for use were for oncology patients where radical resection of the distal femur/proximal tibia is required. The expanded indications for use are limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedure would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications. As with the predicate Kinematic II Rotating Hinge Knee Metal Tibial Bearing Component and the Kinematic II Rotating Hinge Knee Tibial Plugs, the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are single use devices. They are intended for cemented fixation only. The subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are intended to be used in conjunction with the commercially available components of the Modular Replacement System and the Kinematic II Rotating Hinge Knee System.

Source page: https://510kreport.com/device/K992346
Methodology: https://510kreport.com/methodology