# K021380: Oss Les Proximal Femoral Component

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: May 28, 2002 after 27 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: 1 generation back to K002757 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 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)

## 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 OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement. Indications: 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis 2) Correction of varus, valgus or post fraumatic deformity 3) Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement 4) Ligament deficiencies 5) Tumor resections 6) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 7) Revision of previously failed total joint arthroplasty 8) Trauma

Source page: https://510kreport.com/device/K021380
Methodology: https://510kreport.com/methodology