# K051570: Avl Hinge Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 5, 2005 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945028 (1996). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010774: Avl Hinge Knee System, Biomet, Inc. (2001) Summary page 1.
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 1.
- K945028: Finn Knee System, Biomet, Inc. (1996) Summary page 1.

## Most influential descendants
- K120992: Mets Smiles Total Knee Replacement (2012), 3 descendants of its own
- K133152: JTS Extendible Distal Femoral Implant (2014), 2 descendants of its own
- K140900: Patient Specific Smiles Total Knee Replacement (2015), 0 descendants of its own
- K140898: Patient Specific Distal Femoral (2015), 0 descendants of its own

## Indications for use
The indications for use of the AVL Hinge Knee 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 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 arthroplasty 8. Trauma These devices are for cemented use only

Source page: https://510kreport.com/device/K051570
Methodology: https://510kreport.com/methodology