510(k) Report

510(k) · Cleared

Cleared

MPO Total Knee Systems MR Labeling

K152631510(k) TraditionalCleared Mar 23, 2016190-day reviewClass II21 CFR 888.3530

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

Microport Orthopedics, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Mar 23, 2016 as substantially equivalent to K142550 (Microport Orthopedics, Inc., 2014) and 18 other predicates after a 190-day review. Its family tree reaches back 5 generations to 2004. 1 of the 23 devices in its family, counting itself, has a Class I recall.

Decided
Mar 23, 2016
Review
190 days
Class
Class II
Product code
HRY
Recalls
None
Predicates
19

Its longest line of descent runs back 5 generations to K033890 (2004). 22 ancestors in all, the oldest K894334 (1989). No later device cites it as a predicate yet. 1 of the 23 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2014: 1 other ancestor2013: 1 other ancestor2010: 1 other ancestor2007: 2 other ancestors2006: 1 other ancestor, 1 with a Class I recall12005: 1 other ancestor1999: 1 other ancestor1997: 3 other ancestors1996: 2 other ancestors1994: 2 other ancestors1993: 1 other ancestor1989: 1 other ancestorK033890 · Advance Double High Insert · Wrightmedicaltechnologyinc · 2004K102380 · Evolution MP Total Knee System · Wrightmedicaltechnologyinc · 2011 · recalledK113325 · Evolution MP Adaptive CS Insert · Wrightmedicaltechnologyinc · 2011K131679 · Evolution MP Adaptive PS Tibial Insert · Wrightmedicaltechnologyinc · 2013K140735 · Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts · Microport Orthopedics, Inc. · 2014 · recalled1985199019952000200520102015
Other ancestors, by generation 1 generation back: 15 other ancestors, 1 with a Class I recall12 generations back: 2 other ancestors K140735 · Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts · Microport Orthopedics, Inc. · 2014 · recalledK131679 · Evolution MP Adaptive PS Tibial Insert · Wrightmedicaltechnologyinc · 2013K113325 · Evolution MP Adaptive CS Insert · Wrightmedicaltechnologyinc · 2011K102380 · Evolution MP Total Knee System · Wrightmedicaltechnologyinc · 2011 · recalledK033890 · Advance Double High Insert · Wrightmedicaltechnologyinc · 2004−50
  1. Root · 5 generations backK033890 Advance Double High InsertWrightmedicaltechnologyinc · 2004
  2. 4 generations backK102380 Evolution MP Total Knee SystemWrightmedicaltechnologyinc · 2011 · Recalled
  3. 3 generations backK113325 Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011
  4. 2 generations backK131679 Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc · 2013
  5. 1 generation backK140735 Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · Recalled
  6. This deviceK152631 MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc. · 2016

Class I recalls in this family

  • K061223 Advance Total Knee Systemdirect predicate · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K033890Advance Double High InsertWrightmedicaltechnologyinc2004—
−4K102380Evolution MP Total Knee SystemWrightmedicaltechnologyinc20114
−3K113325Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc2011—
−2K131679Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc2013—
−1K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc.20141
0 (this device)K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199310
199420
199620
199730
199910
200510
200611
200720
201010
201310
201410
FIG. 1 — Lineage of K152631, 2004–2016Source: 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.

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 HRY device

  1. #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (19)

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
*K142550EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments
Summary page 4
…Orthopedics/87/MBH, JWH, HRY Predicate Devices: EVOLUTION® Revision Stemmed Femur (K142550) EVOLUTION® MP CS/CR Porous Femur…
Microport Orthopedics, Inc.2014—
*K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts
Summary page 4
…UTION® MP CS/CR Porous Femur & EVOLUTION® Adaptive CS and PS Inserts (K140735) K152631 Page 2/4 EVOLUTION® MP Adaptive PS Tibial Insert (K131679) ADVANC…
Microport Orthopedics, Inc.20141
*K131679Evolution MP Adaptive PS Tibial Insert
Summary page 5
…Inserts (K140735) K152631 Page 2/4 EVOLUTION® MP Adaptive PS Tibial Insert (K131679) ADVANCE® TOTAL KNEE SYSTEM- PATELLA (K122218) EVOLUTION® MP Adaptive CS Insert (…
Wrightmedicaltechnologyinc2013—
*K122218Advance Total Knee System-Patella
Summary page 5
…K152631 Page 2/4 EVOLUTION® MP Adaptive PS Tibial Insert (K131679) ADVANCE® TOTAL KNEE SYSTEM- PATELLA (K122218) EVOLUTION® MP Adaptive CS Insert (K113325) EVOLUTION® MP Total Knee System (K093…
Wrightmedicaltechnologyinc2013—
*K113325Evolution MP Adaptive CS Insert
Summary page 5
…ve PS Tibial Insert (K131679) ADVANCE® TOTAL KNEE SYSTEM- PATELLA (K122218) EVOLUTION® MP Adaptive CS Insert (K113325) EVOLUTION® MP Total Knee System (K093552) ADVANCE STATURE® Femoral Component (K0…
Wrightmedicaltechnologyinc2011—
*K093552Evolution MP Total Knee System
Summary page 5
…AL KNEE SYSTEM- PATELLA (K122218) EVOLUTION® MP Adaptive CS Insert (K113325) EVOLUTION® MP Total Knee System (K093552) ADVANCE STATURE® Femoral Component (K063731) ADVANCE® Spiked Porous Tibial Base…
Wrightmedicaltechnologyinc20105
*K063731Advance Stature Femoral Component
Summary page 5
…MP Adaptive CS Insert (K113325) EVOLUTION® MP Total Knee System (K093552) ADVANCE STATURE® Femoral Component (K063731) ADVANCE® Spiked Porous Tibial Base (K063128) ADVANCE® TOTAL KNEE SYSTEM (K061223…
Wrightmedicaltechnologyinc2007—
*K063128Advance Spiked Porous Tibial Base
Summary page 5
…Total Knee System (K093552) ADVANCE STATURE® Femoral Component (K063731) ADVANCE® Spiked Porous Tibial Base (K063128) ADVANCE® TOTAL KNEE SYSTEM (K061223) ADVANCE® HA Coated Components (K043083)…
Wrightmedicaltechnologyinc2007—
*K061223Advance Total Knee System
Summary page 5
…STATURE® Femoral Component (K063731) ADVANCE® Spiked Porous Tibial Base (K063128) ADVANCE® TOTAL KNEE SYSTEM (K061223) ADVANCE® HA Coated Components (K043083) ADVANCE® Double High Insert (K033890)…
Wrightmedicaltechnologyinc2006Class I
*K043083Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel
Summary page 5
…ANCE® Spiked Porous Tibial Base (K063128) ADVANCE® TOTAL KNEE SYSTEM (K061223) ADVANCE® HA Coated Components (K043083) ADVANCE® Double High Insert (K033890) ADVANCE® Revision Product Line Extension (…
Wrightmedicaltechnologyinc2005—
*K033890Advance Double High Insert
Summary page 5
…ADVANCE® TOTAL KNEE SYSTEM (K061223) ADVANCE® HA Coated Components (K043083) ADVANCE® Double High Insert (K033890) ADVANCE® Revision Product Line Extension (K990030) ADVANCE® Modular Tibial Component…
Wrightmedicaltechnologyinc2004—
*K990030Advanced Revision Product Line Extension
Summary page 5
…A Coated Components (K043083) ADVANCE® Double High Insert (K033890) ADVANCE® Revision Product Line Extension (K990030) ADVANCE® Modular Tibial Component (K973524) ADVANCE® KNEE SYSTEM (K972626) ADVAN…
Wrightmedicaltechnologyinc1999—
*K973524Advance Modular Tibial Component
Summary page 5
…e High Insert (K033890) ADVANCE® Revision Product Line Extension (K990030) ADVANCE® Modular Tibial Component (K973524) ADVANCE® KNEE SYSTEM (K972626) ADVANCE® TIBIAL COMPONENT (K960617) ULTRACK TOTAL…
Wrightmedicaltechnologyinc19971
*K972626Advance Knee System
Summary page 5
…ADVANCE® Revision Product Line Extension (K990030) ADVANCE® Modular Tibial Component (K973524) ADVANCE® KNEE SYSTEM (K972626) ADVANCE® TIBIAL COMPONENT (K960617) ULTRACK TOTAL KNEE SYSTEM (K953439)…
Wrightmedicaltechnologyinc1997—
*K960617Advance Tibial Component
Summary page 5
…990030) ADVANCE® Modular Tibial Component (K973524) ADVANCE® KNEE SYSTEM (K972626) ADVANCE® TIBIAL COMPONENT (K960617) ULTRACK TOTAL KNEE SYSTEM (K953439) ORTHOLOC® ADVANTIM™ Tibial Base Component (K…
Wrightmedicaltechnologyinc1996—
*K953439Ultrack Total Knee System
Summary page 5
…(K973524) ADVANCE® KNEE SYSTEM (K972626) ADVANCE® TIBIAL COMPONENT (K960617) ULTRACK TOTAL KNEE SYSTEM (K953439) ORTHOLOC® ADVANTIM™ Tibial Base Component (K932858) ORTHOLOC® ADVANTIM™ 5 Degree…
Wrightmedicaltechnologyinc1996—
*K932858Ortholoc Advantim Tibial Base Component
Summary page 5
…CE® TIBIAL COMPONENT (K960617) ULTRACK TOTAL KNEE SYSTEM (K953439) ORTHOLOC® ADVANTIM™ Tibial Base Component (K932858) ORTHOLOC® ADVANTIM™ 5 Degree Tibial Stem (K930228) SECOND GENERATION KNEE SYSTEM…
Dow Corning Wright1994—
*K930228Ortholoc Advantim Tibial Stem 5 Degree
Summary page 5
…YSTEM (K953439) ORTHOLOC® ADVANTIM™ Tibial Base Component (K932858) ORTHOLOC® ADVANTIM™ 5 Degree Tibial Stem (K930228) SECOND GENERATION KNEE SYSTEM (K894334) K152631 Page…
Dow Corning Wright1993—
*K894334Second Generation Knee System
Summary page 5
…al Base Component (K932858) ORTHOLOC® ADVANTIM™ 5 Degree Tibial Stem (K930228) SECOND GENERATION KNEE SYSTEM (K894334) K152631 Page 3/4 DEVICE INFORMATION A. Intended Use MicroPort Total Kne…
Orthomet, Inc.1989—

Also cleared against K142550: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 111 Class I recalls

What does this lineage say?

  • The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • 6 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
  • 3 other devices also cite its predicate K142550.

How does its category compare?

All HRY devices

HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · HRY

1in 2020

2007: 32008: 32010: 12011: 12012: 12013: 12014: 12015: 12016: 12019: 12020: 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRY

138in 2008

2007: 92 days median2008: 138 days median
2007high 138 (2008) · low 92 (2007)2026

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

Recalls per year · HRY

3in 2022

2007: 12008: 12011: 12013: 12016: 12020: 12021: 12022: 3
2007high 3 (2022) · low 0 (2009)2026

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

Adverse event reports per year · HRY

290in 2025

2007: 2632008: 2852009: 2492010: 1802011: 1552012: 1372013: 3832014: 3052015: 3452016: 3432017: 4022018: 6132019: 3672020: 1,0542021: 1,2182022: 8402023: 3962024: 4302025: 290
2007high 1,218 (2021) · low 137 (2012)2025

MAUDE reports naming product code HRY, 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
20073921263
200831381285
20090—0249
20101—0180
20111—1155
20121—0137
20131—1383
20141—0305
20151—0345
20161—1343
20170—0402
20180—0613
20191—0367
20201—11,054
20210—11,218
20220—3840
20230—0396
20240—0430
20250—0290
20260—0—

What is it indicated for?

MPO Total Knee Systems are 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…

Read the full statement (106 words)

MPO Total Knee Systems are 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.

ADVANCE® 913 Medial Pivot Tibial Base and Insert Components (not licensed for sale in Canada) are for use with bone cement.

Porous-Coated Total Knee Replacement Components are for use without bone cement.

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

Indications for use as stated in the FDA summary.

Also cleared against K142550

3 other devices cite the same predicate.

  • K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022
  • K182125EVOLUTION Stemmed CS FemurMicroport Orthopedics, Inc. · 2018
  • K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017

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 HRY

The HRY category page

  • K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC · 2020
  • K190633NanoOrtho NanoKnee® SystemNanoortho, LLC · 2019
  • K150410Restoris Porous Partial Knee SystemMako Surgical Corporation · 2015
  • K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. · 20144 recalls
  • K131167UnivationAesculap Implant Systems, LLC · 20138 recalls

https://510kreport.com/device/K152631 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152631: MPO Total Knee Systems MR Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152631

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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