# K081023: Evolis Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Oct 22, 2008 after 195 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K941847 (1994). 76 ancestors in all.
78 later devices descend from it; 9 cite it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072281: Nexgen Prolong All-Poly Patella, Zimmer, Inc. (2007) Summary page 1.
- K072619: Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral Components, Zimmer, Inc. (2007) Summary page 1.
- K070981: Search Evolution (LC) Total Knee System (Plasmapore), Aesculap Implant Systems, Inc. (2007) Summary page 1.
- K060722: Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component, Zimmer, Inc. (2006) Summary page 1.
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components, Zimmer, Inc. (2003) Summary page 1.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999). Our reading of the summary gave K991561, FDA’s number for Roadrunner, Pep Therapy Device (Dhd Healthcare Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)…”.
- K963148: Nexgen Complete Knee Solution, Zimmer, Inc. (1997) Summary page 2.
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 2.
- K951185: Nexgen Complete Knee Solution 9MM Articular Surface, Zimmer, Inc. (1996) Summary page 2.

## Most influential descendants
- K090988: GMK Total Knee System (2009), 52 descendants of its own
- K102437: GMK Revision Knee System (2010), 34 descendants of its own
- K103170: GMK Revision Knee SC Liners (2011), 28 descendants of its own
- K113571: GMK Resufacing Patella Size 4 (2012), 23 descendants of its own
- K091069: Medacta Bone Screws - Evolis and Versafit (2009), 23 descendants of its own

## Recalls of this device
- Sep 11, 2009 · Not classified · Z-2095-2010: Medacta USA Inc is initiating a recall on the Femoral Sizer, an orthopedic manual surgical instrument, because the "L" and "R" markings are mislabeled which would cause incorrect usage.

## Indications for use
The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: * Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis * avascular necrosis of femoral condyle * post traumatic loss of joint configuration * primary implantation failure.

Source page: https://510kreport.com/device/K081023
Methodology: https://510kreport.com/methodology