# K131393: Mak Oss Femoral Knee Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics Corp.
- Decided: Oct 24, 2013 after 162 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002757 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083779: Mak Oss Knee Femoral Components, Biomet Manufacturing Corp (2009) Summary page 1.
- K123501: Oss Modular Stems, Oss Diaphyseal Segments, Biomet, Inc. (2013) Summary page 1.

## Indications for use
Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System 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/K131393
Methodology: https://510kreport.com/methodology