# K041850: Medallion Modular Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Dec 21, 2004 after 166 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K913231 (1991). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000788: Apex Modular Hip Stem, Apex Surgical, LLC (2000) Summary page 1.
- K012091: Pro-Femur, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K003016: Pro-Femur R, Wrightmedicaltechnologyinc (2000) Summary page 1.
- K000760: Reach Femoral Component, Biomet, Inc. (2000) Summary page 1.

## Most influential descendants
- K130149: U2 Hip System, Expanded Indications for Use (2013), 0 descendants of its own

## Indications for use
1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 5) Revision of previously failed total hip arthroplasty.

Source page: https://510kreport.com/device/K041850
Methodology: https://510kreport.com/methodology