# K052685: Orthopedic Salvage System- Oss

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Oct 27, 2005 after 29 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 2 (0 Class I)
- 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.
11 later devices descend from it; 5 cite it directly.
0 of 13 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
- K190100: USTAR II System (2019), 2 descendants of its own
- K080330: Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female Taper (2008), 2 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

## Recalls of this device
- Nov 7, 2007 · Not classified · Z-2214-2008: Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.
- Nov 7, 2007 · Not classified · Z-2213-2008: Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.

## Indications for use
The OSS bodies are indicated for cemented use only in cases of: 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 post traumatic deformity 3) Correction of 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) Trauma 8) Revision of previously failed total joint arthroplasty

Source page: https://510kreport.com/device/K052685
Methodology: https://510kreport.com/methodology