# K083779: Mak Oss Knee Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Apr 3, 2009 after 105 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: 3 generations back to K002757 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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.
- K051479: RS (Reduced Size) Oss (Orthopedic Salvage System) Additional Components, Biomet Manufacturing, Inc. (2005) Summary page 1.
- K052685: Orthopedic Salvage System- Oss, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K131393: Mak Oss Femoral Knee Components (2013), 0 descendants of its own

## Recalls of this device
- Mar 20, 2012 · Not classified · Z-1438-2012: Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available l

## Indications for use
Biomet's OSS Knee System is intended for use in total knee replacement. Specific indications for these devices 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 of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. Ligament deficiencies 5. Tumor resections 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques 7. Revision of previously failed total joint arthroplasy. 8.. Trauma These devices are to be used with bone cement

Source page: https://510kreport.com/device/K083779
Methodology: https://510kreport.com/methodology