# K141331: Biomet Orthopaedic Salvage System (Oss)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 27, 2014 after 159 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: 4 generations back to K945028 (1996). 12 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 16 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 5.
- K052685: Orthopedic Salvage System- Oss, Biomet, Inc. (2005) Summary page 5.
- K123501: Oss Modular Stems, Oss Diaphyseal Segments, Biomet, Inc. (2013) Summary page 5.
- K051479: RS (Reduced Size) Oss (Orthopedic Salvage System) Additional Components, Biomet Manufacturing, Inc. (2005) Summary page 5.
- K021260: Reduced Size Oncology Salvage System, Biomet, Inc. (2002) Summary page 5.
- K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen, Zimmer, Inc. (2011) Summary page 5.

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

## Indications for use
OSS INDICATIONS 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or 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. Revision of previously failed total joint arthroplasty. 8. Trauma. These devices are to be used with bone cement unless composed of OsseoTi (titanium alloy, not licensed in Canada) or a proximal femur is indicated for use (USA). Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (USA). * Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. COMPRESS INDICATIONS The Compress Segmental Femoral Replacement System is indicated for: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress Segmental Femoral Replacement System components are intended for uncemented use. When components of the Orthopaedic Salvage System are used with Biomet’s Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information.

Source page: https://510kreport.com/device/K141331
Methodology: https://510kreport.com/methodology