510(k) Report

510(k) · Cleared

Cleared

LOSPA II Knee System (EXULT Knee Replacement System)

K200395510(k) SpecialCleared May 7, 202079-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

Corentec Co., Ltd. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on May 7, 2020 as substantially equivalent to K192507 (Corentec Co., Ltd., 2019) and 9 other predicates after a 79-day review. Its family tree reaches back 12 generations to 1994. 2 later devices descend from it.

Decided
May 7, 2020
Review
79 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
10

Its longest line of descent runs back 12 generations to K943462 (1994). 116 ancestors in all, the oldest K870730 (1987). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2019: 1 other ancestor2016: 1 other ancestor2013: 4 other ancestors2012: 2 other ancestors2007: 7 other ancestors2005: 9 other ancestors2017: 1 other ancestor2015: 1 other ancestor2014: 1 other ancestor2010: 2 other ancestors2008: 4 other ancestors2006: 7 other ancestors2004: 10 other ancestors2003: 10 other ancestors2000: 2 other ancestors1996: 4 other ancestors2002: 5 other ancestors1999: 2 other ancestors1998: 5 other ancestors1997: 5 other ancestors1995: 2 other ancestors1993: 3 other ancestors1992: 3 other ancestors1991: 3 other ancestors1990: 2 other ancestors2001: 5 other ancestors1987: 1 other ancestor1994: 1 other ancestor1988: 1 other ancestor2021: 1 descendant cleared2020: 1 descendant clearedK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled×2: 2 generations cleared close together, K033272 (2004), K040166 (2004) K061648 · Depuy Graduated Compartmental Knee (GCK) · DePuy Orthopaedics, Inc. · 2006 · recalledK070849 · Depuy GCK Femoral and Tibial Components · DePuy Orthopaedics, Inc. · 2007K082172 · Mako Modular Knee Compartmental Implant System · Mako Surgical Corporation · 2008 · recalledK090763 · Restoris Multicompartmental Knee (MCK) System · Mako Surgical Corporation · 2009 · recalledK133039 · Restoris Multicompartmental Knee System · Mako Surgical Corporation · 2013K150307 · RESTORIS Multicompartmental Knee System · Mako Surgical Corp. · 2015×2: 2 generations cleared close together, K172326 (2017), K173849 (2018) K190402 · Triathlon Total Knee System-Additional Components · Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 20191990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 26 other ancestors3 generations back: 28 other ancestors4 generations back: 15 other ancestors5 generations back: 22 other ancestors6 generations back: 6 other ancestors 1 generation forward: 2 descendants K190402 · Triathlon Total Knee System-Additional Components · Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019K173849 · Triathlon Total Knee System · Stryker Orthopaedics · 2018 · recalledK172326 · Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System · Stryker Orthopaedics · 2017 · recalledK150307 · RESTORIS Multicompartmental Knee System · Mako Surgical Corp. · 2015K133039 · Restoris Multicompartmental Knee System · Mako Surgical Corporation · 2013K090763 · Restoris Multicompartmental Knee (MCK) System · Mako Surgical Corporation · 2009 · recalledK082172 · Mako Modular Knee Compartmental Implant System · Mako Surgical Corporation · 2008 · recalledK070849 · Depuy GCK Femoral and Tibial Components · DePuy Orthopaedics, Inc. · 2007K061648 · Depuy Graduated Compartmental Knee (GCK) · DePuy Orthopaedics, Inc. · 2006 · recalledK040166 · Depuy Sigma XLK Tibial Inserts · DePuy Orthopaedics, Inc. · 2004K033272 · Depuy Sigma Tibial Inserts · DePuy Orthopaedics, Inc. · 2004 · recalledK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled−10−50
  1. Root · 12 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 8 generations between
  3. 3 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
  4. 2 generations backK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
  5. 1 generation backK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
  6. This deviceK200395 LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020
  7. Descendant · cites it directly · 0 of its ownK212034 LOSPA TKR SystemCorentec Co., Ltd. · 2021
  8. Descendant · cites it directly · 0 of its ownK201851 EXULT Femoral component trial - Left, EXULT Femoral component trial…Corentec Co., Ltd. · 2020
Show all 12 generations
  1. Root · 12 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 11 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
  3. 10 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
  4. 9 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
  5. 8 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
  6. 7 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
  7. 6 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
  8. 5 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
  9. 4 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
  10. 3 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
  11. 2 generations backK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
  12. 1 generation backK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
  13. This deviceK200395 LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K212034LOSPA TKR SystemCorentec Co., Ltd. · 2021 · cites it directly0descendants
  • K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K943462Darwin Knee SystemJohnson & Johnson Professionals, Inc.19948
−11K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200451
−10K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004—
−9K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.20061
−8K070849Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc.2007—
−7K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation20082
−6K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095
−5K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation2013—
−4K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.2015—
−3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171
−2K173849Triathlon Total Knee SystemStryker Orthopaedics20183
−1K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)2019—
0 (this device)K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.2020—
+1K212034LOSPA TKR SystemCorentec Co., Ltd.2021—
+1K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198810
199020
199130
199230
199330
199410
199520
199640
199750
199850
199920
200020
200150
200250
2003100
2004100
200590
200670
200770
200840
201020
201220
201340
201410
201510
201610
201710
201910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
FIG. 1 — Lineage of K200395, 1994–2021Source: 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? (10)

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
*K192507LOSPA II Knee System
Summary page 4
…ICATIONS FOR USE The intended use of the added specification has not changed as a result of the modification of the predicate device cleared under LOSPA II Knee System, K192507. The LOSPA II Knee System (EXULT Knee Replacement System) is indicated for the treatment of diseases as follows: x Painfu…
Corentec Co., Ltd.2019—
*K130673Lospa Total Knee Replacement System
Summary page 5
…System (EXULT Knee Replacement System) (CR, PS) Femoral Component – K192507 The LOSPA II Knee System (EXULT Knee Replacement System) Instrumentation – K192507, K110404, K130673, K160157 DEVICE DESCRIPTION The Additional components being added to the LOSPA II Knee Replacement System (EXULT Knee Replacem…
Corentec Co., Ltd.20132
*K110404Eaum Total Knee System
Summary page 5
…A II Knee System (EXULT Knee Replacement System) (CR, PS) Femoral Component – K192507 The LOSPA II Knee System (EXULT Knee Replacement System) Instrumentation – K192507, K110404, K130673, K160157 DEVICE DESCRIPTION The Additional components being added to the LOSPA II Knee Replacement System (EXULT Knee…
Corentec Co., Ltd.20122
*K121037Lospa Tibial Base Plate
Summary page 6
…K110404 Corentec Co. Ltd. LOSPA Knee System K121037 Additional K160157 Predicates…
Corentec Co., Ltd.2012—
*K160157LOSPA Modular Knee System
Summary page 5
…EXULT Knee Replacement System) (CR, PS) Femoral Component – K192507 The LOSPA II Knee System (EXULT Knee Replacement System) Instrumentation – K192507, K110404, K130673, K160157 DEVICE DESCRIPTION The Additional components being added to the LOSPA II Knee Replacement System (EXULT Knee Replacement Syste…
Corentec Co., Ltd.20162
*K190402Triathlon Total Knee System-Additional Components
Summary page 6
…itional K160157 Predicates K190402 K173849 Stryker Orthopa…
Stryker Orthopaedics (Aka Howmedica Osteonics Corp.)2019—
*K173849Triathlon Total Knee System
Summary page 6
…dicates K190402 K173849 Stryker Orthopaedics Triathlon Total Knee System…
Stryker Orthopaedics20183
*K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
Summary page 6
…173849 Stryker Orthopaedics Triathlon Total Knee System K172326 (Aka Howmedica K042343 Osteonics Cor…
Stryker Orthopaedics20171
*K042343Scorpio NRG Knee System
Summary page 6
…K172326 (Aka Howmedica K042343 Osteonics Corp.) Scorpio NRG Knee System K071991 PERFORMANCE TESTING - BENCH The LOSP…
Howmedica Osteonics Corp.20051
*K071991Modification to Scorpio NRG Knee System
Summary page 6
…(Aka Howmedica K042343 Osteonics Corp.) Scorpio NRG Knee System K071991 PERFORMANCE TESTING - BENCH The LOSPA II Knee System (EXULT Knee Replacement System) additional components were justified by a…
Howmedica Osteonics Corp.2007—

Also cleared against K192507: 4 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K212034LOSPA TKR SystemCorentec Co., Ltd.20210
K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200

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 26 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
  • 58 of the 116 ancestors have a recall of any class.
  • Of its descendants, K212034 (Corentec Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K192507.

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. 2020, 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?

LOSPA II Knee System (EXULT Knee Replacement System) is indicated for the treatment of diseases as follows: • Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; • Post-traumatic loss of knee joint configuration and function; • Moderate varus, valgus, or flexion deformity in which the ligamentous structures…

Read the full statement (98 words)

LOSPA II Knee System (EXULT Knee Replacement System) is indicated for the treatment of diseases as follows:

• Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;

• Post-traumatic loss of knee joint configuration and function;

• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;

• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.

LOSPA II Knee System (EXULT Knee Replacement System) is intended for cemented application only.

Indications for use as stated in the FDA summary.

Also cleared against K192507

4 other devices cite the same predicate.

  • K242401EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
  • K242046EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
  • K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd. · 2022
  • K212034LOSPA TKR SystemCorentec Co., Ltd. · 2021

More from Corentec Co., Ltd.

33 FDA decisions under this applicant name. See the company

  • K250889EXULT Knee Replacement SystemCorentec Co., Ltd. · 2025
  • K242401EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
  • K242046EXULT Knee Replacement SystemCorentec Co., Ltd. · 2024
  • K223828BENCOX Delta Option HeadsCorentec Co., Ltd. · 2023
  • K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023

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/K200395 · printed Nov 5, 2026

Cite this page

510(k) Report. “K200395: LOSPA II Knee System (EXULT Knee Replacement System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200395

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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