510(k) Report

510(k) · Cleared

Cleared

Consensus (TM) Total Hip System

K922561510(k) TraditionalCleared Jul 21, 1993413-day reviewClass III21 CFR 888.3320

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. · JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Cleared on Jul 21, 1993 after a 413-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 77 later devices descend from it.

Decided
Jul 21, 1993
Review
413 days
Class
Class III
Product code
JDL
Recalls
None
Predicates
0

77 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2011: 2 descendants cleared2003: 1 descendant cleared2012: 7 descendants cleared2006: 1 descendant cleared2010: 2 descendants cleared2014: 2 descendants cleared2007: 1 descendant cleared2013: 6 descendants cleared2015: 3 descendants cleared2008: 1 descendant cleared2025: 4 descendants cleared2020: 2 descendants cleared2016: 2 descendants cleared2018: 3 descendants cleared2017: 5 descendants cleared2019: 5 descendants cleared2022: 8 descendants cleared2024: 4 descendants cleared2026: 5 descendants cleared2023: 9 descendants cleared2021: 3 descendants cleared1990200020102020
  1. This deviceK922561 Consensus (TM) Total Hip SystemU.S. Medical Products, Inc. · 1993
  2. Descendant · cites it directly · 69 of its ownK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
  3. Descendant · 2 generations on · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
  4. Descendant · cites it directly · 38 of its ownK070061 36MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007
  5. Descendant · cites it directly · 35 of its ownK100933 Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010
  6. Descendant · cites it directly · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

1996: 12003: 12006: 12007: 12008: 12010: 22011: 22012: 72013: 62014: 22015: 32016: 22017: 52018: 32019: 52020: 22021: 32022: 82023: 92024: 42025: 42026: 5
1996high 9 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 77 · See all
  • K060635Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006 · cites it directly69descendants
  • K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012 · 2 generations on53descendants
  • K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007 · cites it directly38descendants
  • K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010 · cites it directly35descendants
  • K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · cites it directly33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922561Consensus (TM) Total Hip SystemU.S. Medical Products, Inc.1993—
+1K060635Consensus Acetabular Shell SystemHayes Medical, Inc.2006—
+2K112802Pipeline Total Hip SystemPipeline Orthopedics2012—
+1K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc.2007—
+1K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.2010—
+1K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200310
200610
200710
200810
201020
201120
201270
201360
201420
201530
201620
201750
201830
201950
202020
202130
202280
202390
202440
202540
202650
FIG. 1 — Lineage of K922561, 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.

Planning a device in JDL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (77)

See all 77

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

NumberDeviceApplicantDecidedDescendants
K060635Consensus Acetabular Shell SystemHayes Medical, Inc.200669
K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc.200738
K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035
K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033
K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc.201421
K960340Consensus Apex Dome Hole PlugU.S. Medical Products, Inc.19965
K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114
K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123
K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121
K031165Plus Orthopedics Cemented Hip StemPlus Orthopedics20031

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, K060635 (Hayes Medical, Inc., 2006) has gone furthest, with 69 descendants of its own.

How does its category compare?

All JDL devices

JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDL

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDL

Too few JDL 510(k)s in any year since 2007 to give a median.

Recalls per year · JDL

1in 2010

2009: 22010: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDL

16in 2025

2007: 792008: 672009: 1042010: 1982011: 2712012: 3382013: 4962014: 5192015: 4662016: 2992017: 3362018: 2052019: 1402020: 942021: 682022: 492023: 322024: 272025: 16
2007high 519 (2014) · low 16 (2025)2025

MAUDE reports naming product code JDL, 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
20071—079
20081—067
20090—2104
20100—1198
20110—0271
20120—0338
20130—0496
20140—0519
20150—0466
20160—0299
20170—0336
20180—0205
20190—0140
20200—094
20210—068
20220—049
20230—032
20240—027
20250—016
20260—1—

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 JDL

The JDL category page

  • K073499Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesZimmer, Inc. · 2008
  • K070785Dynasty Acetabular SystemWrightmedicaltechnologyinc · 2007
  • K061844Dynasty Acetabular Shell and Cocr Acetabular LinerWrightmedicaltechnologyinc · 2006
  • K051995Profemur Renaissance Hip StemWrightmedicaltechnologyinc · 2005
  • K051348Conserve Total Femoral HeadWrightmedicaltechnologyinc · 20052 recalls

https://510kreport.com/device/K922561 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922561: Consensus (TM) Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922561

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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