510(k) Report

510(k) · Cleared

Cleared

Medial Rotation Knee System

K020214510(k) TraditionalCleared Feb 26, 200235-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

Engineering Consulting Services, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 26, 2002 as substantially equivalent to K830726 (Advanced Biosearch Assn., 1983) and 4 other predicates after a 35-day review. Its family tree reaches back 1 generation to 1983. 1 later device descends from it.

Decided
Feb 26, 2002
Review
35 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K830726 (1983). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1986: 1 other ancestor2014: 1 descendant clearedK830726 · Mark I & II Total Knee Replace. Sys · Advanced Biosearch Assn. · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K830726 · Mark I & II Total Knee Replace. Sys · Advanced Biosearch Assn. · 19830
  1. Root · 1 generation backK830726 Mark I & II Total Knee Replace. SysAdvanced Biosearch Assn. · 1983
  2. This deviceK020214 Medial Rotation Knee SystemEngineering Consulting Services, Inc. · 2002
  3. Descendant · cites it directly · 0 of its ownK140222 Saiph Knee SystemMatortho · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K140222Saiph Knee SystemMatortho · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830726Mark I & II Total Knee Replace. SysAdvanced Biosearch Assn.1983—
0 (this device)K020214Medial Rotation Knee SystemEngineering Consulting Services, Inc.2002—
+1K140222Saiph Knee SystemMatortho2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199610
199710
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K020214, 1983–2014Source: 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
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What was it cleared against? (5)

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
*K830726Mark I & II Total Knee Replace. Sys
Summary page 1
…ofemorotibial, Semi-constrained, Cemented, Polymer/Metal/Polymer per 21CFR, Sec 888.3390 DEVICE PRODUCT CODE: 87JWH SUBSTANTIALLY DePuy, Freeman/Samuelson Total Knee (K830726) EQUIVALENT: Sulzermedica, Mark II Freeman/Samuelson Total Knee System (K853730) Biomet, Freeman/Samuleson Total Knee System (K9…
Advanced Biosearch Assn.1983—
*K853730Freeman-Samuelson Mark II Press-Fit Total Knee Rep
Summary page 1
…888.3390 DEVICE PRODUCT CODE: 87JWH SUBSTANTIALLY DePuy, Freeman/Samuelson Total Knee (K830726) EQUIVALENT: Sulzermedica, Mark II Freeman/Samuelson Total Knee System (K853730) Biomet, Freeman/Samuleson Total Knee System (K943025) Wright Medical Technology, Inc., Advance Ultra-Conguent Tibial Insert (K9…
Protek, Inc.1986—
*K943025Freeman/Samuelson Total Knee System
Summary page 1
…Puy, Freeman/Samuelson Total Knee (K830726) EQUIVALENT: Sulzermedica, Mark II Freeman/Samuelson Total Knee System (K853730) Biomet, Freeman/Samuleson Total Knee System (K943025) Wright Medical Technology, Inc., Advance Ultra-Conguent Tibial Insert (K972770) Renaissance Instruments, LLC., FS 1000 Knee Sys…
Biomet, Inc.1996—
*K972770Advance Ultra-Congruent Tibial Insert
Summary page 1
…eeman/Samuelson Total Knee System (K853730) Biomet, Freeman/Samuleson Total Knee System (K943025) Wright Medical Technology, Inc., Advance Ultra-Conguent Tibial Insert (K972770) Renaissance Instruments, LLC., FS 1000 Knee System (K991052) DEVICE DESCRIPTION: The Medial Rotation Knee™ System is both a p…
Wrightmedicaltechnologyinc19972
*K991052FS 1000 Knee System
Summary page 1
…amuleson Total Knee System (K943025) Wright Medical Technology, Inc., Advance Ultra-Conguent Tibial Insert (K972770) Renaissance Instruments, LLC., FS 1000 Knee System (K991052) DEVICE DESCRIPTION: The Medial Rotation Knee™ System is both a primary and revision total knee system composed of a CoCr Femor…
Renaissance Instruments, LLC1999—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140222Saiph Knee SystemMatortho20140

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?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K140222 (Matortho, 2014) has gone furthest, with 0 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.

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 Medial Rotation Knee™ System is intended for single-use ‘cemented’ implantation for use in a total knee arthroplasty surgery for the reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: ¢ Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis…

Read the full statement (92 words)

The Medial Rotation Knee™ System is intended for single-use ‘cemented’ implantation

for use in a total knee arthroplasty surgery for the reduction or relief of pain and/or

improved knee function in skeletally mature patients with the following conditions:

¢ Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or

avascular necrosis;

Inflammatory degenerative joint disease including rheumatoid arthritis;

Correction of varus, valgus, or post traumatic deformity;

Correction or revision of unsuccessful osteotomy or arthrodesis;

Revision procedures where other treatments or devices have failed;

Treatment of fractures that are unmanageable using other techniques;

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K020214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020214: Medial Rotation 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/K020214

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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