# K122015: Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip, Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 22, 2013 after 227 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: 2 generations back to K945028 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020381: Expandable Knee, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 1.
- K965164: Howmedica Modular Replacement System-Proximal Femur, Howmedica Corp. (1997) Summary page 1.

## Indications for use
The Distal Femoral Growing Prosthesis is indicated for pediatric patients who have not achieved full skeletal maturity (open epiphysis), where radical resection and replacement of the distal femur and or/proximal tibia is required with the following conditions: * Oncology indications * Severe trauma * Noninflammatory degenerative joint disease including osteoarthritis * Correction of functional deformity * Rheumatoid arthritis * Revision procedures where other treatments or devices have failed The devices are single use implants intended only for implantation with bone cement. Compatible components of the GMRS, MRH, MRS, and KRH when used with the Distal Femoral Growing Prosthesis are intended for use in pediatric patients for the above-mentioned indications.

Source page: https://510kreport.com/device/K122015
Methodology: https://510kreport.com/methodology