510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Omnifit (TM) Total Knee Prosthesis System

K863668510(k) TraditionalCleared Dec 19, 198692-day reviewClass II21 CFR 888.3560Recalls 4

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

Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 19, 1986 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 4 times.

Decided
Dec 19, 1986
Review
92 days
Class
Class II
Product code
JWH
Recalls
4
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2002: 1 descendant cleared2023: 1 descendant cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK863668 Omnifit (TM) Total Knee Prosthesis SystemOsteonics Corp. · 1986
  2. Descendant · cites it directly · 2 of its ownK170534 Prolixus Total Knee SystemOtis Biotech Co., Ltd. · 2017
  3. Descendant · 2 generations on · 0 of its ownK231975 PNK Total Knee SystemTjc Life Co., Ltd. · 2023
  4. Descendant · 2 generations on · 0 of its ownK191192 SurgTech GENOLL Total Knee SystemSurgtech, Inc. · 2019
  5. Descendant · cites it directly · 0 of its ownK020830 Scorpio Inset Patellar ComponentHowmedica Osteonics Corp. · 2002

Most influential descendants

Showing 4 of 4 · See all
  • K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd. · 2017 · cites it directly2descendants
  • K231975PNK Total Knee SystemTjc Life Co., Ltd. · 2023 · 2 generations on0descendants
  • K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc. · 2019 · 2 generations on0descendants
  • K020830Scorpio Inset Patellar ComponentHowmedica Osteonics Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863668Omnifit (TM) Total Knee Prosthesis SystemOsteonics Corp.1986—
+1K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd.2017—
+2K231975PNK Total Knee SystemTjc Life Co., Ltd.2023—
+2K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc.2019—
+1K020830Scorpio Inset Patellar ComponentHowmedica Osteonics Corp.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201710
201910
202310
FIG. 1 — Lineage of K863668, 1986–2023Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd.20172
K020830Scorpio Inset Patellar ComponentHowmedica Osteonics Corp.20020

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 1, 2023Class IIZ-0869-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0870-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0871-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0872-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K170534 (Otis Biotech Co., Ltd., 2017) has gone furthest, with 2 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—

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

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/K863668 · printed Nov 5, 2026

Cite this page

510(k) Report. “K863668: Omnifit (TM) Total Knee Prosthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K863668

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026