# K083827: Orthopedic Salvage System (Oss) 9CM Cobalt - Chrome Tibial Bodies

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Feb 13, 2009 after 52 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 1 (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.
No later device cites it as a predicate yet.
0 of 2 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.

## Recalls of this device
- Dec 16, 2016 · Class II · Z-1114-2017: labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in su

## Indications for use
1. Painful and disabled knee 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 failure of 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 a proximal femur is indicated (USA). Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage, or any other knee component.

Source page: https://510kreport.com/device/K083827
Methodology: https://510kreport.com/methodology