# K031480: Global Modular Replacement System Pediatric Tibial Bearing Component

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 31, 2003 after 80 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.
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) MRS Pediatric Tibial Bearing Component: named in the summary without a submission number
- (no number) MRH Crossover Tibial Bearing Component: 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 Global Modular Replacement System (GMRSTM) Pediatric Tibial Bearing Component is intended to be used to mate the distal femoral components of the Global Modular Replacement (GMRSTM) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System The indications for use for the GMRSTM Pediatric Tibial Bearing Component are listed below: Indications Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

Source page: https://510kreport.com/device/K031480
Methodology: https://510kreport.com/methodology