# K033871: IM Total Femur

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 16, 2004 after 126 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 K810258 (1981). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 1.
- K974558: Salvage/Onocology Hip and Total Femur System, Biomet, Inc. (1998) Summary page 1.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 1.
- K003296: Biomet SCK Knee System, Biomet, Inc. (2000) Summary page 1.
- K010774: Avl Hinge Knee System, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K152621: OSS/Arcos IM Total Femur Rod (2015), 0 descendants of its own

## Indications for use
Total hip and knee joint replacement in cases of: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis 2. Correction of varus, valgus or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 4. Ligament deficiencies 5. Tumor resections 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques 7. Revision of previously failed total joint replacement 8. Trauma

Source page: https://510kreport.com/device/K033871
Methodology: https://510kreport.com/methodology