510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Evolution MP Total Knee System

K093552510(k) TraditionalCleared Mar 4, 2010107-day reviewClass II21 CFR 888.3560Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 4, 2010 after a 107-day review. The FDA summary names no predicate by number. 38 later devices descend from it. It has been recalled 5 times.

Decided
Mar 4, 2010
Review
107 days
Class
Class II
Product code
JWH
Recalls
5
Predicates
0

38 later devices descend from it, 15 citing it directly.

Descendants, by year cleared 2015: 4 descendants cleared2017: 1 descendant cleared2010: 1 descendant cleared2025: 6 descendants cleared2011: 2 descendants cleared2019: 2 descendants cleared2014: 1 descendant cleared2013: 2 descendants cleared2024: 3 descendants cleared2016: 1 descendant cleared2026: 4 descendants cleared2022: 3 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2021: 3 descendants cleared2023: 2 descendants cleared2010201520202025
  1. This deviceK093552 Evolution MP Total Knee SystemWrightmedicaltechnologyinc · 2010
  2. Descendant · cites it directly · 18 of its ownK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
  3. Descendant · cites it directly · 11 of its ownK102380 Evolution MP Total Knee SystemWrightmedicaltechnologyinc · 2011 · Recalled
  4. Descendant · 2 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
  5. Descendant · 2 generations on · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
  6. Descendant · 3 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22013: 22014: 12015: 42016: 12017: 12018: 12019: 22020: 22021: 32022: 32023: 22024: 32025: 62026: 4
2010high 6 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 38 · See all
  • K141934Physica KR Knee SystemLima Corporate S.P.A. · 2015 · cites it directly18descendants
  • K102380Evolution MP Total Knee SystemWrightmedicaltechnologyinc · 2011 · cites it directly11descendants
  • K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 2 generations on8descendants
  • K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on8descendants
  • K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K093552Evolution MP Total Knee SystemWrightmedicaltechnologyinc2010—
+1K141934Physica KR Knee SystemLima Corporate S.P.A.2015—
+1K102380Evolution MP Total Knee SystemWrightmedicaltechnologyinc20114
+2K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate2019—
+2K151266Physica CR Knee SystemLima Corporate S.P.A.2015—
+3K220792SMR Reverse LinerLima Corporate S.P.A.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201320
201410
201540
201610
201710
201810
201920
202020
202130
202230
202320
202430
202560
202640
FIG. 1 — Lineage of K093552, 2010–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (38)

See all 38

15 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141934Physica KR Knee SystemLima Corporate S.P.A.201518
K102380Evolution MP Total Knee SystemWrightmedicaltechnologyinc201111
K113325Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc20117
K131679Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc20136
K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc.20145
K182251EVOLUTION NitrX Medial-Pivot KneeMircoport Orthopedics, Inc.20194
K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc.20173
K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251
K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.20260
K244039MedalOne Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 29, 2024Class IIZ-0699-2025Labeling Change ControlFemoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
May 3, 2024Class IIZ-2244-2024Under Investigation by firmOne confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous…
Oct 28, 2022Class IIZ-0276-2023Nonconforming Material/ComponentOne confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
Oct 28, 2022Class IIZ-0275-2023Nonconforming Material/ComponentOne confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
Feb 2, 2015Class IIZ-1249-2015Device DesignSome units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K141934 (Lima Corporate S.P.A., 2015) has gone furthest, with 18 descendants of its own.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

The EVOLUTIONTM MP Total Knee System is indicated for use in knee artbroplasty in skeletally mature patients with the following conditions:

1. noninflammuatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascLular necrosis;

2. inflammatory degenerative joint disease including rheumatoid arthritis;

3. correction of functional deformity;

4. revision procedures where other treatments or devices have failed; and

5. treatment of fractures that are unmanageable using other techniques.

EVOLUTIONTM MP Total Knee System non-porous components are for cemented use only.

Indications for use as stated in the FDA summary.

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

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Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K093552 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093552: Evolution MP Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093552

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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