510(k) · Cleared
Recalled · 2009Evolis Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 22, 2008 as substantially equivalent to K072281 (Zimmer, Inc., 2007) and 8 other predicates after a 195-day review. Its family tree reaches back 7 generations to 1994. 78 later devices descend from it. It has been recalled once.
- Decided
- Oct 22, 2008
- Review
- 195 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 9
Its longest line of descent runs back 7 generations to K941847 (1994). 76 ancestors in all, the oldest K840643 (1984). 78 later devices descend from it, 9 citing it directly.
- Root · 7 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 5 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 4 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 2 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 1 generation backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- This deviceK081023 Evolis Total Knee SystemMedacta International S.A. · 2008
- Descendant · cites it directly · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- Descendant · 2 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- Descendant · 2 generations on · 28 of its ownK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- Descendant · cites it directly · 23 of its ownK113571 GMK Resufacing Patella Size 4Medacta International · 2012
- Descendant · cites it directly · 23 of its ownK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K090988GMK Total Knee SystemMedacta International S.A. · 2009 · cites it directly52descendants
- K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 2 generations on34descendants
- K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 2 generations on28descendants
- K113571GMK Resufacing Patella Size 4Medacta International · 2012 · cites it directly23descendants
- K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009 · cites it directly23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −6 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −5 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −4 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −1 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| 0 (this device) | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | — |
| +1 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| +2 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| +2 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| +1 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
| +1 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 9 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 9 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072281 | Nexgen Prolong All-Poly PatellaSummary page 1…Classification Name: Knee joint patellofemorotibial metal/polymer/metal semniconstrained cemented prosthesis, 21 CFR 868.3560, product code JWH Predicate Devices: K072281, NexGen® Prolong All-Poly Patella; K07261 9, NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component; K070981, Search Ev… | 2007 |
| * | K072619 | Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Summary page 1…lofemorotibial metal/polymer/metal semniconstrained cemented prosthesis, 21 CFR 868.3560, product code JWH Predicate Devices: K072281, NexGen® Prolong All-Poly Patella; K07261 9, NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component; K070981, Search Evolution (LC) Total Knee System, K060722, Nex… | 2007 |
| * | K070981 | Search Evolution (LC) Total Knee System (Plasmapore)Summary page 1…CFR 868.3560, product code JWH Predicate Devices: K072281, NexGen® Prolong All-Poly Patella; K07261 9, NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component; K070981, Search Evolution (LC) Total Knee System, K060722, NexGen& Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articula… | 2007 |
| * | K060722 | Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface…Summary page 1…K072281, NexGen® Prolong All-Poly Patella; K07261 9, NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component; K070981, Search Evolution (LC) Total Knee System, K060722, NexGen& Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component; K031061, NexGen® Porous, Unce… | 2006 |
| * | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsSummary page 1…Component; K070981, Search Evolution (LC) Total Knee System, K060722, NexGen& Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component; K031061, NexGen® Porous, Uncemented Femoral and Tibial Baseplate Components; K991 561, NexGen® Complete Knee Solution Legacy® Posterior S… | 2003 |
| * | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing… 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)…”. | 1999 |
| * | K963148 | Nexgen Complete Knee SolutionSummary page 2…(LPS), LPS-Flex Fixed Bearing Femoral and Articular Surface Components; Evolis Total Knee System 510O(k) Section 5 -Page 2 of 4 K963148, NexGen® Complete Knee Solution Fluted Stemmed Tibial Component. K960279, NexGen® Legacy PS (L-PS) and NexGen® CCK (L-CCK) K95118… | 1997 |
| * | K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…Summary page 2…Evolis Total Knee System 510O(k) Section 5 -Page 2 of 4 K963148, NexGen® Complete Knee Solution Fluted Stemmed Tibial Component. K960279, NexGen® Legacy PS (L-PS) and NexGen® CCK (L-CCK) K951185, NexGen® Total Knee Solution 9 mm Tibial Articular Surface Product Des… | 1996 |
| * | K951185 | Nexgen Complete Knee Solution 9MM Articular SurfaceSummary page 2…Section 5 -Page 2 of 4 K963148, NexGen® Complete Knee Solution Fluted Stemmed Tibial Component. K960279, NexGen® Legacy PS (L-PS) and NexGen® CCK (L-CCK) K951185, NexGen® Total Knee Solution 9 mm Tibial Articular Surface Product Description: The Evolis Total Knee System is a tricompartment… | 1996 |
What descends from it? (78)
See all 789 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090988 | GMK Total Knee System | 2009 | 52 |
| K113571 | GMK Resufacing Patella Size 4 | 2012 | 23 |
| K091069 | Medacta Bone Screws - Evolis and Versafit | 2009 | 23 |
| K121416 | GMK Sphere | 2012 | 20 |
| K120790 | GMK - Line Extension | 2012 | 11 |
| K142069 | GMK Extension | 2014 | 4 |
| K131310 | GMK Full PE Tibial Components | 2013 | 2 |
| K122975 | GKS Prime Flex CR Total Knee System | 2012 | 0 |
| K111283 | GMK Revision Hybrid Liners | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2009 | Not classified | Z-2095-2010 | Process design | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 30 of the 75 ancestors have a recall of any class.
- Of its descendants, K090988 (Medacta International S.A., 2009) has gone furthest, with 52 descendants of its own.
- 4 other devices also cite its predicate K072281.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081023 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081023: Evolis Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081023
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026