510(k) Report

510(k) · Cleared

Cleared

Optigen Total Knee System

K102367510(k) TraditionalCleared Dec 8, 2010110-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

U&I Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 8, 2010 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 10 other predicates after a 110-day review. Its family tree reaches back 2 generations to 1995.

Decided
Dec 8, 2010
Review
110 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
11

Its longest line of descent runs back 2 generations to K933785 (1995). 12 ancestors in all, the oldest K884796 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor1999: 2 other ancestors1995: 1 other ancestor1994: 1 other ancestor1992: 2 other ancestors1989: 3 other ancestorsK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalledK023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalled198519901995200020052010
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 1 other ancestor K023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalledK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalled0
  1. Root · 2 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
  2. 1 generation backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
  3. This deviceK102367 Optigen Total Knee SystemU&I Corp. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933785Next Generation Knee SystemZimmer, Inc.199583
−1K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsZimmer, Inc.20026
0 (this device)K102367Optigen Total Knee SystemU&I Corp.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198930
199220
199410
199510
199920
200210
FIG. 1 — Lineage of K102367, 1995–2010Source: 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? (11)

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
*K951987Genesis II Total Knee System
Summary page 1
…semi- constrained cemented prosthesis, per 21 CFR 888.3560 Product Code: JWH Predicate Devices: Genesis 11Total Knee System - K951 987 Maxim Knee System - K9151 32, K922285, K993159 PY.C Sigma Knee System - K884796…
Smith & Nephew Richards, Inc.19956
*K915132MCK Maximum Congruent Knee) Knee System
Summary page 1
…rosthesis, per 21 CFR 888.3560 Product Code: JWH Predicate Devices: Genesis 11Total Knee System - K951 987 Maxim Knee System - K9151 32, K922285, K993159 PY.C Sigma Knee System - K884796, K892394, K935262 NexGen CR-…
Biomet, Inc.19926
*K922285Agc and Maxim Knee Components with NTS
Summary page 1
…per 21 CFR 888.3560 Product Code: JWH Predicate Devices: Genesis 11Total Knee System - K951 987 Maxim Knee System - K9151 32, K922285, K993159 PY.C Sigma Knee System - K884796, K892394, K935262 NexGen CR-Flex, LPS…
Biomet, Inc.1992—
*K993159Maxim Knee System
Summary page 1
…FR 888.3560 Product Code: JWH Predicate Devices: Genesis 11Total Knee System - K951 987 Maxim Knee System - K9151 32, K922285, K993159 PY.C Sigma Knee System - K884796, K892394, K935262 NexGen CR-Flex, LPS-Flex Sys…
Biomet, Inc.1999—
*K884796P.F.C.(TM) Modular Knee System
Summary page 1
…s: Genesis 11Total Knee System - K951 987 Maxim Knee System - K9151 32, K922285, K993159 PY.C Sigma Knee System - K884796, K892394, K935262 NexGen CR-Flex, LPS-Flex System - K933785, K023211 U2 Total K…
Johnson & Johnson Professionals, Inc.198916
*K892394P.F.C. Modular Knee System, Tibial Tray-Porous
Summary page 1
…Genesis 11Total Knee System - K951 987 Maxim Knee System - K9151 32, K922285, K993159 PY.C Sigma Knee System - K884796, K892394, K935262 NexGen CR-Flex, LPS-Flex System - K933785, K023211 U2 Total Knee Syste…
Johnson & Johnson Professionals, Inc.1989—
*K935262P.F.C. Total Knee System Oval Patella
Summary page 1
…1Total Knee System - K951 987 Maxim Knee System - K9151 32, K922285, K993159 PY.C Sigma Knee System - K884796, K892394, K935262 NexGen CR-Flex, LPS-Flex System - K933785, K023211 U2 Total Knee System - K0216…
Johnson & Johnson Orthopaedics, Inc.1994—
*K933785Next Generation Knee System
Summary page 1
…ystem - K9151 32, K922285, K993159 PY.C Sigma Knee System - K884796, K892394, K935262 NexGen CR-Flex, LPS-Flex System - K933785, K023211 U2 Total Knee System - K021657 MG 11Porous Total Knee System - K892800…
Zimmer, Inc.199583
*K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components
Summary page 1
…9151 32, K922285, K993159 PY.C Sigma Knee System - K884796, K892394, K935262 NexGen CR-Flex, LPS-Flex System - K933785, K023211 U2 Total Knee System - K021657 MG 11Porous Total Knee System - K892800 Desc…
Zimmer, Inc.20026
*K021657Uknee Total Knee System
Summary page 1
…Sigma Knee System - K884796, K892394, K935262 NexGen CR-Flex, LPS-Flex System - K933785, K023211 U2 Total Knee System - K021657 MG 11Porous Total Knee System - K892800 Description of Device: OptiGen Tm Total Knee System consist…
United Orthopedic Corp.2002—
*K892800MG II Porous Total Knee System
Summary page 1
…NexGen CR-Flex, LPS-Flex System - K933785, K023211 U2 Total Knee System - K021657 MG 11Porous Total Knee System - K892800 Description of Device: OptiGen Tm Total Knee System consists of femoral components(PS, CR), tibial components, tibial bearin…
Zimmer, Inc.198970

Also cleared against K951987: 31 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
  • 7 of the 12 ancestors have a recall of any class.
  • 31 other devices also cite its predicate K951987.

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. 2010, 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 OptiGenm Total Knee System is indicated for patients with severe knee pain and disability due to:

* Rheumatoid arthritis

* Post-traumatic arthritis, osteoarthritis, or degenerative arthritis

* Failed osteotomies, unicompartmental replacement, or total knee replacement

* Moderate varus, valgus, or flexion deformities

This device is indicated for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K951987

31 other devices cite the same predicate.

  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K221939Cemented Round Patella with JRNY PegsSmith & Nephew, Inc. · 2022
  • K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021
  • K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 202111 recalls
  • K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc. · 2017
  • K162775Legion Cone SystemSmith & Nephew, Inc. · 20172 recalls

More from U&I Corp.

12 FDA decisions under this applicant name. See the company

  • K140864Veloxtm Interbody Fusion SystemU&I Corp. · 2014
  • K140234Aspiron Acp SystemU&I Corp. · 2014
  • K132926Velofixtm Interbody Fusion SystemU&I Corp. · 2014
  • K120419Dyna Locking Ankle NailU&I Corp. · 2012
  • K112240Dyna Locking Cannulated ScrewU&I Corp. · 2012

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/K102367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102367: Optigen Total 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/K102367

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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