# K101815: Enduro Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems
- Decided: Dec 20, 2010 after 173 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: 5 generations back to K915192 (1992). 16 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee, Zimmer, Inc. (2002) Summary page 1.
- K083772: Columbus Revision Knee System, Aesculap Implant System, Inc. (2009) Summary page 1.

## Most influential descendants
- K130299: GMK Hinge (2013), 4 descendants of its own
- K120955: Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System (2012), 4 descendants of its own
- K143443: VEGA Knee System, Columbus Total Knee System (2015), 3 descendants of its own
- K191765: OMNI TiN Coated Apex Knee™ System (2019), 2 descendants of its own
- K172347: GMK Hinge, GMK Revision (2017), 2 descendants of its own

## Indications for use
The EnduRo Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws. The EnduRo Knee System is intended for cemented use only.

Source page: https://510kreport.com/device/K101815
Methodology: https://510kreport.com/methodology