# K253515: Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Aug 24, 2026 after 290 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: 12 generations back to K810258 (1981). 129 ancestors in all.
No later device cites it as a predicate yet.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141331: Biomet Orthopaedic Salvage System (Oss), Biomet, Inc. (2014) Summary page 5.
- K142814: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial, Biomet Manufacturing, LLC (2015) 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 OsseoTi® titanium alloy or a proximal femur is indicated for use (USA).

Source page: https://510kreport.com/device/K253515
Methodology: https://510kreport.com/methodology