# K253434: OSSTM Orthopedic Salvage System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 1, 2026 after 273 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: 2 generations back to K002757 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123501: Oss Modular Stems, Oss Diaphyseal Segments, Biomet, Inc. (2013) Summary page 5.

## Indications for use
OSS System Indications: • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. • Correction of varus, valgus, or posttraumatic deformity. • Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Ligament deficiencies. • Tumor resections. • Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. * • Revision of previously failed total joint arthroplasty. • Trauma. These devices are to be used with bone cement unless composed of Osseo Ti® titanium alloy (not licensed in Canada) or a proximal femur is indicated for use (USA). Zimmer 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 (Solely indicated for the USA). * Not applicable to Regenerex® Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. Compress System Indications: The Compress Segmental Femoral Replacement System is indicated for: • Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Tumor resections. • Revision of previously failed total joint arthroplasty. • Trauma. The Compress Segmental Femoral Replacement System components are intended for uncemented use. When components of the OSS System are used with Zimmer Biomet Compress Segmental Femoral Replacement System, the user should refer to the package insert of the Zimmer Biomet Compress Segmental Femoral Replacement System components for information.

Source page: https://510kreport.com/device/K253434
Methodology: https://510kreport.com/methodology