510(k) Report

510(k) · Cleared

Cleared

Kinematic II Replacement Tibial Inserts

K960976510(k) TraditionalCleared Aug 7, 1996149-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

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

Cleared on Aug 7, 1996 as substantially equivalent to K823420 (Howmedica Corp., 1983) and 2 other predicates after a 149-day review. Its family tree reaches back 1 generation to 1983.

Decided
Aug 7, 1996
Review
149 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K823420 (1983). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestorsK823420 · Kinematic II Knee System · Howmedica Corp. · 19831980198519901995
Other ancestors, by generation 1 generation back: 2 other ancestors K823420 · Kinematic II Knee System · Howmedica Corp. · 19830
  1. Root · 1 generation backK823420 Kinematic II Knee SystemHowmedica Corp. · 1983
  2. This deviceK960976 Kinematic II Replacement Tibial InsertsHowmedica Corp. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K823420Kinematic II Knee SystemHowmedica Corp.1983—
0 (this device)K960976Kinematic II Replacement Tibial InsertsHowmedica Corp.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
FIG. 1 — Lineage of K960976, 1983–1996Source: 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? (3)

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
*K823420Kinematic II Knee System
Summary page 1
…equivalent to other legally marketed devices in commercial distribution. These devices are: 1. Kinematic® II Condylar Cruciate Retaining Tibial Component - Howmedica (K823420) 2. Kinematic® II Total Condylar Tibial Component - Howmedica (K823420) 3. Kinematic® II Stabilizer Tibial Component - Howmedi…
Howmedica Corp.1983—
*K936008Duracon Baseplates
Summary page 1
…mponent - Howmedica (K823420) 3. Kinematic® II Stabilizer Tibial Component - Howmedica (K823420) 4. P.C.A. Primary Tibial Inserts for Duracon® Baseplates - Howmedica (K936008) 5. P.C.A. Modular Tibial Inserts for Duracon® Baseplates - Howmedica (K940861) This equivalence is based upon similarities in…
Howmedica Corp.19952
*K940861Pca (R) Modular Total Knee Tib Insert Durocon Baseplate
Summary page 1
…owmedica (K823420) 4. P.C.A. Primary Tibial Inserts for Duracon® Baseplates - Howmedica (K936008) 5. P.C.A. Modular Tibial Inserts for Duracon® Baseplates - Howmedica (K940861) This equivalence is based upon similarities in intended use, material, and design to the legally marketed devices. Testing was…
Howmedica Corp.19957

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?

  • 2 of the 3 ancestors have a recall of any class.

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 Kinematic® II Replacement Tibial Inserts are intended to be used in the revision of an existing Kinematic® II tibial component assembly. These inserts are intended to be used when the Vitallium baseplate portion of the tibial assembly is well fixed by cement, but the polyethylene bearing portion of the tibial assembly needs revision due to wear or ligament laxity.

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

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

Recent decisions in JWH

The JWH category page

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  • 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/K960976 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960976: Kinematic II Replacement Tibial Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960976

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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