# K123501: Oss Modular Stems, Oss Diaphyseal Segments

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Feb 27, 2013 after 106 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.
6 later devices descend from it; 4 cite it directly.
0 of 8 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.

## 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
- K253515: Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments (2026), 0 descendants of its own
- K253434: OSSTM Orthopedic Salvage System (2026), 0 descendants of its own
- K152621: OSS/Arcos IM Total Femur Rod (2015), 0 descendants of its own

## Indications for use
Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. Correction of varus, valgus or post-traumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. Ligament deficiencies. 5. Tumor resections. 6. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.* 7. Revision of previously failed total joint arthroplasty. 8. Trauma. These devices are to be used with bone cement unless a proximal femur is indicated for use (USA). *Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for: 1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma.

Source page: https://510kreport.com/device/K123501
Methodology: https://510kreport.com/methodology