# K051479: RS (Reduced Size) Oss (Orthopedic Salvage System) Additional Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Aug 10, 2005 after 68 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 K002757 (2000). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 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.
- K021260: Reduced Size Oncology Salvage System, Biomet, Inc. (2002) Summary page 1.

## Most influential descendants
- K141331: Biomet Orthopaedic Salvage System (Oss) (2014), 3 descendants of its own
- K142814: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (2015), 1 descendant of its own
- K083779: Mak Oss Knee Femoral Components (2009), 1 descendant of its own
- K253515: Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments (2026), 0 descendants of its own
- K152621: OSS/Arcos IM Total Femur Rod (2015), 0 descendants of its own

## Indications for use
1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, functional or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement. 4. Ligament deficiencies. 5. Tumor resections. 6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 7. Trauma. 8. Revision of previously failed total joint arthroplasty. The RS OSS Components are intended for cemented use only.

Source page: https://510kreport.com/device/K051479
Methodology: https://510kreport.com/methodology