# K020970: Modification to Oncology Salvage System (Oss)

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Apr 4, 2002 after 9 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur. Indications: 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis 2) Correction of varus, valgus, 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 arthroplasty 8) Trauma These devices are single use implants. These devices are for cemented use only.

Source page: https://510kreport.com/device/K020970
Methodology: https://510kreport.com/methodology