510(k) Report

510(k) · Cleared

Cleared

Consensus Knee System - Primary Knee

K932837510(k) TraditionalCleared Sep 27, 1994473-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.S. Medical Products, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Sep 27, 1994 after a 473-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided
Sep 27, 1994
Review
473 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

16 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2011: 2 descendants cleared2013: 2 descendants cleared1998: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2025: 2 descendants cleared2019: 2 descendants cleared2020: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK932837 Consensus Knee System - Primary KneeU.S. Medical Products, Inc. · 1994
  2. Descendant · cites it directly · 7 of its ownK133919 Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
  3. Descendant · cites it directly · 3 of its ownK163167 CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
  4. Descendant · 2 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
  5. Descendant · cites it directly · 2 of its ownK160515 PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
  6. Descendant · cites it directly · 2 of its ownK120038 A200 Knee SystemRenovis Surgical Technologies, LLC · 2013

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1998: 12011: 22013: 22014: 12015: 12016: 12017: 12019: 22020: 12021: 12024: 12025: 2
1998high 2 (2011) · low 0 (1999)2026

Most influential descendants

Showing 5 of 16 · See all
  • K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014 · cites it directly7descendants
  • K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017 · cites it directly3descendants
  • K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 2 generations on2descendants
  • K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016 · cites it directly2descendants
  • K120038A200 Knee SystemRenovis Surgical Technologies, LLC · 2013 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932837Consensus Knee System - Primary KneeU.S. Medical Products, Inc.1994—
+1K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.2014—
+1K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.2017—
+2K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.2019—
+1K160515PS2 Knee SystemConsensus Orthopedics, Inc.2016—
+1K120038A200 Knee SystemRenovis Surgical Technologies, LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
201120
201320
201410
201510
201610
201710
201920
202010
202110
202410
202520
FIG. 1 — Lineage of K932837, 1994–2025Source: 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
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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? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147
K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173
K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162
K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132
K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111
K983004Consensus Femoral Component, Porous, Cocr/TIHayes Medical, Inc.19981
K150496Total Knee Arthroplasty SystemResponsive Orthopedics, LLC20150

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?

  • Of its descendants, K133919 (Consensus Orthopedics, Inc., 2014) has gone furthest, with 7 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 U.S. Medical Products, Inc.

24 FDA decisions under this applicant name. See the company

  • K962215Consensus Posterior Stabilized Knee-Intercondylar Notch RouterU.S. Medical Products, Inc. · 1996
  • K954818Consensus Posterior Stabilized KneeU.S. Medical Products, Inc. · 1996
  • K953443Consensus PCL Subsituting Tibial InsertU.S. Medical Products, Inc. · 1996
  • K960302Consensus Acetabular Shell, All UhmwpeU.S. Medical Products, Inc. · 1996
  • K952943Consensus All Poly TibiaU.S. Medical Products, Inc. · 1996

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/K932837 · printed Nov 5, 2026

Cite this page

510(k) Report. “K932837: Consensus Knee System - Primary Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932837

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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