# K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 9, 2002 after 89 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945028 (1996). 1 ancestor in all.
54 later devices descend from it; 9 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945028: Finn Knee System, Biomet, Inc. (1996) Summary page 1.

## Most influential descendants
- K070978: Zimmer Segmental System (2007), 13 descendants of its own
- K143179: The LINK® Endo-Model® Knee System (2015), 11 descendants of its own
- K081111: Legion Hinge Knee System (2008), 11 descendants of its own
- K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen (2011), 10 descendants of its own
- K101815: Enduro Knee System (2010), 10 descendants of its own

## Recalls of this device
- Aug 3, 2004 · Not classified · Z-1448-04: The polyethylene tibial bushing was omitted from the taper of the tibial plates.
- Aug 3, 2004 · Not classified · Z-1447-04: The polyethylene tibial bushing was omitted from the taper of the tibial plates.

## Indications for use
This device is indicated for moderate to severe knee instability, significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, valgus, varus, or flexion deformities and/or for the salvage of previously failed surgical attempts This device is intended for cemented use only.

Source page: https://510kreport.com/device/K013385
Methodology: https://510kreport.com/methodology