# K060131: Oss-Bodies Proximal Tibial Sleeve

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Feb 15, 2006 after 28 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: 2 generations back to K002757 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052685: Orthopedic Salvage System- Oss, Biomet, Inc. (2005) Summary page 1.

## Indications for use
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 *Not applicable to Regenerex TM Ultra Porous Construct titanium knee augment usage, or any other knee component. These devices are single use implants. These devices are for cemented use only

Source page: https://510kreport.com/device/K060131
Methodology: https://510kreport.com/methodology