# K072367: Repiphysis Limb Salvage Proximal Femur and Total Femur

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 9, 2008 after 139 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) REPIPHYSIS® Limb Salvage System: named in the summary without a submission number
- (no number) GUARDIAN™ Limb Salvage System: named in the summary without a submission number

## Indications for use
The REPIPHYSIS Limb Salvage Proximal Femur and REPIPHYSIS Limb Salvage Total Femur are indicated for cemented procedures where radical resection and replacement of the proximal or total femur is required in skeletally immature patients (weighing up to 67 lbs) with osteosarcoma. REPIPHYSIS Limb Salvage Proximal and Total Femur devices are intended for cemented use only.

Source page: https://510kreport.com/device/K072367
Methodology: https://510kreport.com/methodology