510(k) Report

510(k) · Cleared

Cleared

Evolution MP Adaptive CS Insert

K113325510(k) SpecialCleared Dec 9, 201129-day reviewClass II21 CFR 888.3560

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 Dec 9, 2011 as substantially equivalent to K093552 (Wrightmedicaltechnologyinc, 2010) and 5 other predicates after a 29-day review. Its family tree reaches back 2 generations to 2004. 7 later devices descend from it.

Decided
Dec 9, 2011
Review
29 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K033890 (2004). 7 ancestors in all, the oldest K894334 (1989). 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor1997: 2 other ancestors1989: 1 other ancestor2007: 1 other ancestor2014: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared2016: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant clearedK033890 · Advance Double High Insert · Wrightmedicaltechnologyinc · 2004K102380 · Evolution MP Total Knee System · Wrightmedicaltechnologyinc · 2011 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K102380 · Evolution MP Total Knee System · Wrightmedicaltechnologyinc · 2011 · recalledK033890 · Advance Double High Insert · Wrightmedicaltechnologyinc · 20040
  1. Root · 2 generations backK033890 Advance Double High InsertWrightmedicaltechnologyinc · 2004
  2. 1 generation backK102380 Evolution MP Total Knee SystemWrightmedicaltechnologyinc · 2011 · Recalled
  3. This deviceK113325 Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011
  4. Descendant · cites it directly · 6 of its ownK131679 Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc · 2013
  5. Descendant · cites it directly · 5 of its ownK140735 Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
  7. Descendant · 3 generations on · 0 of its ownK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  8. Descendant · cites it directly · 0 of its ownK240043 EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW…Microport Orthopedics, Inc. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12016: 12022: 12024: 12025: 12026: 1
2013high 1 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K131679Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc · 2013 · cites it directly6descendants
  • K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · cites it directly5descendants
  • K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · 2 generations on1descendant
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026 · 3 generations on0descendants
  • K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K033890Advance Double High InsertWrightmedicaltechnologyinc2004—
−1K102380Evolution MP Total Knee SystemWrightmedicaltechnologyinc20114
0 (this device)K113325Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc2011—
+1K131679Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc2013—
+1K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc.20141
+2K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and…Microport Orthopedics, Inc.2025—
+3K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.2026—
+1K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal…Microport Orthopedics, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199720
200710
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201610
202210
202410
202510
202610
FIG. 1 — Lineage of K113325, 2004–2026Source: 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? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K093552Evolution MP Total Knee System
Summary page 1
…AXIOM® Total Knee System 510(k)s: K894334, K972626, K972770, K033890 K093552, K102380 DEVICE INFORMATION A. Intended Use The EVOLUTION® MP Adaptive CS Insert is indicated for use in knee arthroplasty in s…
Wrightmedicaltechnologyinc20105
*K102380Evolution MP Total Knee System
Summary page 1
…otal Knee System 510(k)s: K894334, K972626, K972770, K033890 K093552, K102380 DEVICE INFORMATION A. Intended Use The EVOLUTION® MP Adaptive CS Insert is indicated for use in knee arthroplasty in skeletally…
Wrightmedicaltechnologyinc20114
*K894334Second Generation Knee System
Summary page 1
…ADVANCE® Total Knee System AXIOM® Total Knee System 510(k)s: K894334, K972626, K972770, K033890 K093552, K102380 DEVICE INFORMATION A. Intended Us…
Orthomet, Inc.1989—
*K972626Advance Knee System
Summary page 1
…ADVANCE® Total Knee System AXIOM® Total Knee System 510(k)s: K894334, K972626, K972770, K033890 K093552, K102380 DEVICE INFORMATION A. Intended Use The EVO…
Wrightmedicaltechnologyinc1997—
*K033890Advance Double High Insert
Summary page 1
…e System AXIOM® Total Knee System 510(k)s: K894334, K972626, K972770, K033890 K093552, K102380 DEVICE INFORMATION A. Intended Use The EVOLUTION® MP Adaptiv…
Wrightmedicaltechnologyinc2004—
*K972770Advance Ultra-Congruent Tibial Insert
Summary page 1
…Total Knee System AXIOM® Total Knee System 510(k)s: K894334, K972626, K972770, K033890 K093552, K102380 DEVICE INFORMATION A. Intended Use The EVOLUTION® M…
Wrightmedicaltechnologyinc19972

Also cleared against K093552: 14 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K131679Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc20136
K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc.20145
K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc.20240
K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.20160

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 7.0 years on median.
  • 3 of the 7 ancestors have a recall of any class.
  • Of its descendants, K131679 (Wrightmedicaltechnologyinc, 2013) has gone furthest, with 6 descendants of its own.
  • 14 other devices also cite its predicate K093552.

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. 2011, 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 EVOLUTION® MP Adaptive CS Insert is indicated for use in knee arthroplasty, in skeletally mature patients with 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;

4. Revision procedures where other treatments or devices have failed; and treatment of fractures that

are unmanageable using other techniques.

The EVOLUTION® Total Knee System is for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K093552

14 other devices cite the same predicate.

  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K244039MedalOne Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2025
  • K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025
  • K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™…Microport Orthopedics, Inc. · 2024
  • K182251EVOLUTION NitrX Medial-Pivot KneeMircoport Orthopedics, Inc. · 2019
  • K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

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  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

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/K113325 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113325: Evolution MP Adaptive CS Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113325

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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