510(k) Report

510(k) · Cleared

Cleared

Total Knee Cemented, Semi-Constrained

K021740510(k) TraditionalCleared Sep 23, 2002118-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

Dj Orthopedics, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Sep 23, 2002 as substantially equivalent to K973412 (Sulzer Orthopedics, Inc., 1997) after a 118-day review. Its family tree reaches back 1 generation to 1997. 52 later devices descend from it.

Decided
Sep 23, 2002
Review
118 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K973412 (1997). 52 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 2 descendants cleared2006: 1 descendant cleared2016: 6 descendants cleared2008: 1 descendant cleared2019: 2 descendants cleared2012: 5 descendants cleared2013: 4 descendants cleared2011: 2 descendants cleared2022: 3 descendants cleared2014: 6 descendants cleared2025: 2 descendants cleared2024: 1 descendant cleared2018: 1 descendant cleared2026: 2 descendants cleared2020: 3 descendants cleared2015: 1 descendant cleared2021: 5 descendants cleared2023: 5 descendants clearedK973412 · Natural-Knee II Constrained Knee System · Sulzer Orthopedics, Inc. · 1997 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 9 descendants4 generations forward: 8 descendants5 generations forward: 6 descendants6 generations forward: 8 descendants7 generations forward: 5 descendants8 generations forward: 2 descendants9 generations forward: 3 descendants10 generations forward: 3 descendants11 generations forward: 2 descendants K973412 · Natural-Knee II Constrained Knee System · Sulzer Orthopedics, Inc. · 1997 · recalled0+5+10
  1. Root · 1 generation backK973412 Natural-Knee II Constrained Knee SystemSulzer Orthopedics, Inc. · 1997 · Recalled
  2. This deviceK021740 Total Knee Cemented, Semi-ConstrainedDj Orthopedics, LLC · 2002
  3. Descendant · cites it directly · 43 of its ownK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006
  4. Descendant · 2 generations on · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
  5. Descendant · 3 generations on · 40 of its ownK103117 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · Recalled
  6. Descendant · 3 generations on · 38 of its ownK112780 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011
  7. Descendant · 3 generations on · 36 of its ownK120316 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12010: 22011: 22012: 52013: 42014: 62015: 12016: 62018: 12019: 22020: 32021: 52022: 32023: 52024: 12025: 22026: 2
2006high 6 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 52 · See all
  • K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006 · cites it directly43descendants
  • K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · 2 generations on41descendants
  • K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on40descendants
  • K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on38descendants
  • K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012 · 3 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K973412Natural-Knee II Constrained Knee SystemSulzer Orthopedics, Inc.19972
0 (this device)K021740Total Knee Cemented, Semi-ConstrainedDj Orthopedics, LLC2002—
+1K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.2006—
+2K094050Itotal CR Knee Replacement SystemConformis, Inc.2010—
+3K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20111
+3K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011—
+3K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201020
201120
201250
201340
201460
201510
201660
201810
201920
202030
202150
202230
202350
202410
202520
202620
FIG. 1 — Lineage of K021740, 1997–2026Source: 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? (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
*K973412Natural-Knee II Constrained Knee System
Summary page 1
…ence: The Active Knee@ System is substantially equivalent to the Sulzer Orthopedics Natural-Knee II Constrained Knee System, K973412. Product Description: Device Svstem The Active Knee System i…
Sulzer Orthopedics, Inc.19972

Also cleared against K973412: 3 other devices →

What descends from it? (52)

See all 52

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

NumberDeviceApplicantDecidedDescendants
K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.200643
K160159Active-X Total Knee SystemSignature Orthopaedics Pty, Ltd.20166
K093567Active Knee Total Knee Replacement SystemAnova Implant Solutions, LLC20100

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?

  • Its one ancestor has a recall.
  • Of its descendants, K052687 (Conformis, Inc., 2006) has gone furthest, with 43 descendants of its own.
  • 3 other devices also cite its predicate K973412.

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 Alaron Surgical Active Knee@System is semi-constrained and is intended to be

used only with bone cement in patients suffering from the following conditions:

Non-inflammatory degenerative joint disease including osteoarthritis, traumatic

arthritis, or avascular necrosis.

Inflammatory degenerative joint disease including rheumatoid arthritis.

Correction of functional deformity such as varus, valgus, or flexion deformities.

Revision procedures where other treatments or devices have failed.

Treatment of fractures that are unmanageable using other techniques.

Indications for use as stated in the FDA summary.

Also cleared against K973412

3 other devices cite the same predicate.

  • K181947Persona Revision Knee SystemZimmer, Inc. · 20181 recall
  • K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 20182 recalls
  • K060192Apex Knee SystemOmni Life Science, Inc. · 20061 recall

More from Dj Orthopedics, LLC

6 FDA decisions under this applicant name. See the company

  • K011354High Tibial Osteotomy Plating SystemDj Orthopedics, LLC · 2001
  • K010594DJ Orthopedics Post ScrewDj Orthopedics, LLC · 2001
  • K010595DJ Orthopedics Interference ScrewDj Orthopedics, LLC · 2001
  • K002829DJ Orthopedics Femoral AnchorDj Orthopedics, LLC · 2001
  • K003960DJ Orthopedics Tibial AnchorDj Orthopedics, LLC · 2001

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/K021740 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021740: Total Knee Cemented, Semi-Constrained.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021740

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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