# K053094: Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Bio-Surfaces, Inc.
- Decided: Feb 6, 2006 after 95 days
- Product code: HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented))
- Device class: 2
- Regulation: 21 CFR 888.3590
- 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 K911802 (1992). 6 ancestors in all.
1 later device descends 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)
- K003269: Unicondylar Interpositional Spacer, Sulzer Orthopedics, Inc. (2001) Summary page 1.
- K033242: Knee Interpositional Mini-Repair System (Kimrs), Imaging Therapeutics, Inc. (2003) Summary page 1.

## Most influential descendants
- K073233: Orthoglide Lateral Knee Implant and Instruments (2008), 0 descendants of its own

## Indications for use
The Orthoglide Medial Knee Implant is intended for use in the osteoarthritic knee, where substantial amounts of cartilage have been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the medial compartment of the knee (grade II-IV chondromalacia) with no more than minimal degeneration (grade I-Il chondromalacia, no loss of joint space) in the lateral and patellofemoral compartments in patients with ostcoarthritis.

Source page: https://510kreport.com/device/K053094
Methodology: https://510kreport.com/methodology