510(k) Report

510(k) · Cleared

Cleared

Femoral & Tibial Augment Block

K924940510(k) TraditionalCleared Mar 9, 1993160-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

Joint Medical Products Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 9, 1993 after a 160-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 65 devices in its family, counting itself, have a Class I recall. 64 later devices descend from it.

Decided
Mar 9, 1993
Review
160 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

64 later devices descend from it, 2 citing it directly. 2 of the 65 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2001: 1 descendant cleared2024: 4 descendants cleared2004: 3 descendants cleared, 1 with a Class I recall12007: 3 descendants cleared, 1 with a Class I recall12008: 1 descendant cleared2021: 8 descendants cleared2006: 2 descendants cleared2020: 7 descendants cleared2013: 2 descendants cleared2012: 2 descendants cleared2019: 6 descendants cleared2014: 1 descendant cleared2025: 5 descendants cleared2022: 4 descendants cleared2023: 9 descendants cleared2018: 4 descendants cleared2016: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK924940 Femoral & Tibial Augment BlockJoint Medical Products Corp. · 1993
  2. Descendant · cites it directly · 63 of its ownK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
  3. Descendant · 2 generations on · 54 of its ownK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
  4. Descendant · 3 generations on · 36 of its ownK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
  5. Descendant · 3 generations on · 31 of its ownK063633 Depuy Knee Prosthesis System Universal Stem Extensions and Femoral…DePuy Orthopaedics, Inc. · 2007 · Recalled
  6. Descendant · 4 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2001: 12004: 32006: 22007: 32008: 12012: 22013: 22014: 12016: 12018: 42019: 62020: 72021: 82022: 42023: 92024: 42025: 52026: 1
2001high 9 (2023) · low 0 (2002)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 64 · See all
  • K003182Orthogenesis LPS SystemDepuy, Inc. · 2001 · cites it directly63descendants
  • K040281LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004 · 2 generations on54descendants
  • K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006 · 3 generations on36descendants
  • K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · 3 generations on31descendants
  • K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 4 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924940Femoral & Tibial Augment BlockJoint Medical Products Corp.1993—
+1K003182Orthogenesis LPS SystemDepuy, Inc.2001—
+2K040281LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc.2004—
+3K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc.2006—
+3K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal…DePuy Orthopaedics, Inc.20071
+4K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200431
200620
200731
200810
201220
201320
201410
201610
201840
201960
202070
202180
202240
202390
202440
202550
202610
FIG. 1 — Lineage of K924940, 1993–2026Source: 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.

2 devices in this family have a Class I recall. 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?

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

What descends from it? (64)

See all 64

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

NumberDeviceApplicantDecidedDescendants
K003182Orthogenesis LPS SystemDepuy, Inc.200163
K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K041085LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryDepuy, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
  • K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

  • Of its descendants, K003182 (Depuy, Inc., 2001) has gone furthest, with 63 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—
Cite this page

510(k) Report. “K924940: Femoral & Tibial Augment Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924940

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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