510(k) · Cleared
ClearedEvolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 18, 2025 as substantially equivalent to K140735 (Microport Orthopedics, Inc., 2014) and 9 other predicates after a 91-day review. Its family tree reaches back 16 generations to 1994. 1 of the 202 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Feb 18, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 16 generations to K941847 (1994). 201 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly. 1 of the 202 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations between
- 3 generations backK140826 GMK Sphere ExtensionMedacta International · 2014
- 2 generations backK162035 GMK SphereMedacta International S.A. · 2017
- 1 generation backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- This deviceK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 15 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 14 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 13 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 12 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 11 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 10 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 9 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 8 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 7 generations backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- 6 generations backK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- 5 generations backK113571 GMK Resufacing Patella Size 4Medacta International · 2012
- 4 generations backK121416 GMK SphereMedacta International · 2012
- 3 generations backK140826 GMK Sphere ExtensionMedacta International · 2014
- 2 generations backK162035 GMK SphereMedacta International S.A. · 2017
- 1 generation backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- This deviceK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
Class I recalls in this family
- K061223 Advance Total Knee System2 generations back · 2006
Most influential descendants
Showing 1 of 1 · See all- K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −15 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −14 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −13 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −12 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −11 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −10 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −9 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −8 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −7 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| −6 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| −5 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
| −4 | K121416 | GMK Sphere | Medacta International | 2012 | — |
| −3 | K140826 | GMK Sphere Extension | Medacta International | 2014 | — |
| −2 | K162035 | GMK Sphere | Medacta International S.A. | 2017 | — |
| −1 | K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018 | — |
| 0 (this device) | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and… | Microport Orthopedics, Inc. | 2025 | — |
| +1 | K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 12 | 0 |
| 1995 | 13 | 0 |
| 1996 | 13 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 11 | 0 |
| 2003 | 10 | 0 |
| 2004 | 7 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 1 |
| 2007 | 12 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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.
1 device in this family has a Class I recall. 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? (10)
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 |
|---|---|---|---|
| * | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code � K140735 Evolution® MP CS/CR Porous Femur �M_B _H… | 2014 |
| * | K093552 | Evolution MP Total Knee SystemSummary page 5…CR Porous Femur �M_B _H ___� K093552 Evolution® MP Total Knee System �J_W_H___� K102380 Evol… | 2010 |
| * | K102380 | Evolution MP Total Knee SystemSummary page 5…___� K093552 Evolution® MP Total Knee System �J_W_H___� K102380 Evolution® MP Total Knee System �J_W_H___� K 152298 Evol… | 2011 |
| * | K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE…Summary page 5…nee System �J_W_H___� K102380 Evolution® MP Total Knee System �J_W_H___� K 152298 Evolution® Biofoam® Tibia Base and Modular Keels MBH K 16 2026 Evolution® R… | 2015 |
| * | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION…Summary page 5…Total Knee System �J_W_H___� K 152298 Evolution® Biofoam® Tibia Base and Modular Keels MBH K 16 2026 Evolution® Revision Tibia Base System JWH K 170288 Evolution® Bi… | 2017 |
| * | K170288 | BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION®…Summary page 5…on® Biofoam® Tibia Base and Modular Keels MBH K 16 2026 Evolution® Revision Tibia Base System JWH K 170288 Evolution® Biofoam® Tibia Base with Biofoam® Additive Manufj MBH… | 2017 |
| * | K182125 | EVOLUTION Stemmed CS FemurSummary page 6…�----� K243574 - Page 2 of 3 K182125 I Evolution® Stem m ed CS Fem ur JWH K182251… | 2018 |
| * | K182251 | EVOLUTION NitrX Medial-Pivot KneeSummary page 6…K243574 - Page 2 of 3 K182125 I Evolution® Stem m ed CS Fem ur JWH K182251 Evolution® NitrX ™ Medial-P ivotKnee JWH K173890… | 2019 |
| * | K173890 | GMK Sphere - Kinematic AlignmentSummary page 6…JWH K182251 Evolution® NitrX ™ Medial-P ivotKnee JWH K173890 �I G_ M_K_S _p_he_ re _ _ e_n_t__________… | 2018 |
| * | K172524 | Zimmer Persona Personalized Knee SystemSummary page 6…�I JWH � _ _ ____, K172524 I Zim m er Persona PersonalizedKnee System I MBH Device De… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061223Advance Total Knee SystemWrightmedicaltechnologyinc · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 111 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 78 of the 200 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K253728 (Microport Orthopedics, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K140735.
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. 2025, 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 Evolution® Total Knee Systems can be implanted using the Kinematic Alignment technique.
When the Kinematic Alignment approach is utilized, the devices are indicated for the following
conditions:
1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or
avascular necrosis;
2) inflammatory degenerative joint disease including rheumatoid arthritis;
3) correction of functional deformity;
The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary Knee
components or the Evolution® Stemmed CS Femur and Evolution® Revision Tibia Base.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243574 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243574
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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