510(k) Report

510(k) · Cleared

Cleared

EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

K162026510(k) TraditionalCleared Mar 1, 2017222-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

Microport Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 1, 2017 as substantially equivalent to K152298 (Microport Orthopedics, Inc., 2015) after a 222-day review. Its family tree reaches back 3 generations to 2005. 7 later devices descend from it.

Decided
Mar 1, 2017
Review
222 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K043083 (2005). 7 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedReference device: K061223 · Advance Total Knee System · Wrightmedicaltechnologyinc · 2006 · Class I recallReference device: K973524 · Advance Modular Tibial Component · Wrightmedicaltechnologyinc · 1997 · recalledReference device: K990030 · Advanced Revision Product Line Extension · Wrightmedicaltechnologyinc · 1999Reference device: K093552 · Evolution MP Total Knee System · Wrightmedicaltechnologyinc · 2010 · recalledK043083 · Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel · Wrightmedicaltechnologyinc · 2005K143366 · ADVANCE Porous Coated Spiked Tibial Base · Microport Orthopedics, Inc. · 2015K152298 · EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base · Microport Orthopedics, Inc. · 201520052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 2 descendants K152298 · EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base · Microport Orthopedics, Inc. · 2015K143366 · ADVANCE Porous Coated Spiked Tibial Base · Microport Orthopedics, Inc. · 2015K043083 · Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel · Wrightmedicaltechnologyinc · 20050
  1. Root · 3 generations backK043083 Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular…Wrightmedicaltechnologyinc · 2005
  2. 2 generations backK143366 ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc. · 2015
  3. 1 generation backK152298 EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE…Microport Orthopedics, Inc. · 2015
  4. This deviceK162026 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block…Microport Orthopedics, Inc. · 2017
  5. Descendant · cites it directly · 3 of its ownK171389 EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017
  6. Descendant · cites it directly · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
  7. Descendant · 2 generations on · 0 of its ownK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  8. Descendant · 2 generations on · 0 of its ownK240043 EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW…Microport Orthopedics, Inc. · 2024
  9. Descendant · cites it directly · 0 of its ownK231947 EVOLUTION® Cement KeelMicroport Orthopedics, Inc. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12022: 12023: 12024: 12025: 12026: 1
2017high 1 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 7 · See all
  • K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017 · cites it directly3descendants
  • K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · cites it directly1descendant
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026 · 2 generations on0descendants
  • K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc. · 2024 · 2 generations on0descendants
  • K231947EVOLUTION® Cement KeelMicroport Orthopedics, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K043083Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular KeelWrightmedicaltechnologyinc2005—
−2K143366ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc.2015—
−1K152298EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels…Microport Orthopedics, Inc.2015—
0 (this device)K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment…Microport Orthopedics, Inc.2017—
+1K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc.2017—
+1K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and…Microport Orthopedics, Inc.2025—
+2K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.2026—
+2K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal…Microport Orthopedics, Inc.2024—
+1K231947EVOLUTION® Cement KeelMicroport Orthopedics, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
202210
202310
202410
202510
202610
FIG. 1 — Lineage of K162026, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (1)

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
*K152298EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE…
Summary page 4
…lass II Subject Product Code and Panel Orthopedics/87/JWH Code: Predicate Device: EVOLUTION® BIOFOAM® Tibial System (K152298) Reference Devices: ADVANCE® Total Knee System (K061223)…
Microport Orthopedics, Inc.2015—
†K061223Advance Total Knee SystemWrightmedicaltechnologyinc2006Class I
†K973524Advance Modular Tibial ComponentWrightmedicaltechnologyinc19971
†K990030Advanced Revision Product Line ExtensionWrightmedicaltechnologyinc1999—
†K093552Evolution MP Total Knee SystemWrightmedicaltechnologyinc20105

Also cleared against K152298: 4 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc.20173
K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251
K231947EVOLUTION® Cement KeelMicroport Orthopedics, Inc.20230
K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc.20220
K180317EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION®…Microport Orthopedics, Inc.20180

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 12 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K171389 (Microport Orthopedics, Inc., 2017) has gone furthest, with 3 descendants of its own.
  • 4 other devices also cite its predicate K152298.

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. 2017, 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® Revision Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory 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® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K152298

4 other devices cite the same predicate.

  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025
  • K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022
  • K180317EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System…Microport Orthopedics, Inc. · 2018

More from Microport Orthopedics, Inc.

52 FDA decisions under this applicant name. See the company

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K250444NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025
  • K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025
  • K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024

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/K162026 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162026: EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162026

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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