510(k) Report

510(k) · Cleared

Cleared

Kinemax Plus Tibial Spacers

K964951510(k) TraditionalCleared Feb 24, 199776-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 Feb 24, 1997 as substantially equivalent to K915512 (Pfizer Hospital Products Group, Inc., 1992) and 7 other predicates after a 76-day review. Its family tree reaches back 1 generation to 1987.

Decided
Feb 24, 1997
Review
76 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
9

Its longest line of descent runs back 1 generation to K872379 (1987). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 4 other ancestors1990: 2 other ancestors1989: 1 other ancestorK872379 · Insall/Burstein* II Modular Total Knee · Zimmer, Inc. · 1987 · recalled1986198819901992199419961998
Other ancestors, by generation 1 generation back: 7 other ancestors K872379 · Insall/Burstein* II Modular Total Knee · Zimmer, Inc. · 1987 · recalled0
  1. Root · 1 generation backK872379 Insall/Burstein* II Modular Total KneeZimmer, Inc. · 1987 · Recalled
  2. This deviceK964951 Kinemax Plus Tibial SpacersHowmedica Corp. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K872379Insall/Burstein* II Modular Total KneeZimmer, Inc.198711
0 (this device)K964951Kinemax Plus Tibial SpacersHowmedica Corp.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199020
199240
FIG. 1 — Lineage of K964951, 1987–1997Source: 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? (9)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K915512Duracon Total Knee System Tibial Components
Summary page 1
…Plus Tibial Spacers are substantially equivalent to other legally marketed products. Examples of these products are listed below: 1. Duracon® Tibial Wedges - Howmedica (K915512) 2. Kinemax® Angled Tibial Wedge - Howmedica (K884837) 3 Insall-Burstein Il Half and Full Tibial Wedges - Zimmer (K872379) 4. Max…
Pfizer Hospital Products Group, Inc.19924
*K884837Kinemax Tibial Wedge
Summary page 1
…her legally marketed products. Examples of these products are listed below: 1. Duracon® Tibial Wedges - Howmedica (K915512) 2. Kinemax® Angled Tibial Wedge - Howmedica (K884837) 3 Insall-Burstein Il Half and Full Tibial Wedges - Zimmer (K872379) 4. Maxim Tibial Augmentation Blocks - Biomet (K915132 and K9…
Howmedica Corp.1989—
*K872379Insall/Burstein* II Modular Total Knee
Summary page 1
…below: 1. Duracon® Tibial Wedges - Howmedica (K915512) 2. Kinemax® Angled Tibial Wedge - Howmedica (K884837) 3 Insall-Burstein Il Half and Full Tibial Wedges - Zimmer (K872379) 4. Maxim Tibial Augmentation Blocks - Biomet (K915132 and K922285) 5. CKS Tibial Spacers - Techmedica (K896542, KS01457, K903286…
Zimmer, Inc.198711
*K915132MCK Maximum Congruent Knee) Knee System
Summary page 1
…) 2. Kinemax® Angled Tibial Wedge - Howmedica (K884837) 3 Insall-Burstein Il Half and Full Tibial Wedges - Zimmer (K872379) 4. Maxim Tibial Augmentation Blocks - Biomet (K915132 and K922285) 5. CKS Tibial Spacers - Techmedica (K896542, KS01457, K903286, and K914072) An analysis of equivalent features was…
Biomet, Inc.19926
*K922285Agc and Maxim Knee Components with NTS
Summary page 1
…® Angled Tibial Wedge - Howmedica (K884837) 3 Insall-Burstein Il Half and Full Tibial Wedges - Zimmer (K872379) 4. Maxim Tibial Augmentation Blocks - Biomet (K915132 and K922285) 5. CKS Tibial Spacers - Techmedica (K896542, KS01457, K903286, and K914072) An analysis of equivalent features was presented.…
Biomet, Inc.1992—
*K896542Addition to the Continuum Knee System (CKS (TM))
Summary page 1
…Insall-Burstein Il Half and Full Tibial Wedges - Zimmer (K872379) 4. Maxim Tibial Augmentation Blocks - Biomet (K915132 and K922285) 5. CKS Tibial Spacers - Techmedica (K896542, KS01457, K903286, and K914072) An analysis of equivalent features was presented. For information contact: Margaret F. Crowe Ma…
Techmedica, Inc.1990—
Kept off the family treeK901457FDA’s K901457 is Continuum Knee System (CKS)
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Techmedica, Inc.1990—
*K903286Continuum Knee System (CKS)-Modification
Summary page 1
…l Half and Full Tibial Wedges - Zimmer (K872379) 4. Maxim Tibial Augmentation Blocks - Biomet (K915132 and K922285) 5. CKS Tibial Spacers - Techmedica (K896542, KS01457, K903286, and K914072) An analysis of equivalent features was presented. For information contact: Margaret F. Crowe Manager, Regulatory…
Techmedica, Inc.1990—
*K914072Continuum Knee System (CKS)
Summary page 1
…ll Tibial Wedges - Zimmer (K872379) 4. Maxim Tibial Augmentation Blocks - Biomet (K915132 and K922285) 5. CKS Tibial Spacers - Techmedica (K896542, KS01457, K903286, and K914072) An analysis of equivalent features was presented. For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howme…
Techmedica, Inc.1992—

Also cleared against K915512: 2 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?

  • 3 of the 8 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K915512.

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 Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia.

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

Also cleared against K915512

2 other devices cite the same predicate.

  • K970758Duracon Extra-Small Stabilizer Tibial Insert & BaseplateHowmedica Corp. · 1997
  • K963242Duracon Posterior Femoral SpacerHowmedica Corp. · 1996

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

  • 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/K964951 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964951: Kinemax Plus Tibial Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964951

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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