510(k) Report

510(k) · Cleared

Cleared

Modular Unipolar System

K902365510(k) TraditionalCleared Jan 11, 1991226-day reviewClass II21 CFR 888.3360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Howmedica Corp. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal

Cleared on Jan 11, 1991 after a 226-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 185 later devices descend from it.

Decided
Jan 11, 1991
Review
226 days
Class
Class II
Product code
KWL
Recalls
None
Predicates
0

185 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2016: 11 descendants cleared2002: 2 descendants cleared1996: 1 descendant cleared2011: 3 descendants cleared2018: 12 descendants cleared2019: 18 descendants cleared2022: 11 descendants cleared2020: 16 descendants cleared2021: 12 descendants cleared2023: 10 descendants cleared1999: 1 descendant cleared2001: 1 descendant cleared2012: 7 descendants cleared2026: 13 descendants cleared2025: 15 descendants cleared2024: 12 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2006: 4 descendants cleared2008: 2 descendants cleared2013: 9 descendants cleared2017: 8 descendants cleared2009: 1 descendant cleared2015: 7 descendants cleared2014: 6 descendants cleared1990200020102020
  1. This deviceK902365 Modular Unipolar SystemHowmedica Corp. · 1991
  2. Descendant · cites it directly · 121 of its ownK960538 Opteon UnipolarExactech, Inc. · 1996
  3. Descendant · 2 generations on · 117 of its ownK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
  4. Descendant · 3 generations on · 116 of its ownK042037 M2A Magnum SystemBiomet, Inc. · 2004
  5. Descendant · 4 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
  6. Descendant · 5 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled

Showing 5 of 185 descendants. See all descendants

Descendants cleared per year

1996: 11999: 12001: 12002: 22004: 12005: 12006: 42007: 12008: 22009: 12011: 32012: 72013: 92014: 62015: 72016: 112017: 82018: 122019: 182020: 162021: 122022: 112023: 102024: 122025: 152026: 13
1996high 18 (2019) · low 0 (1997)2026

Most influential descendants

Showing 5 of 185 · See all
  • K960538Opteon UnipolarExactech, Inc. · 1996 · cites it directly121descendants
  • K984028The New Bio-Moore Endo HeadsBiomet, Inc. · 1999 · 2 generations on117descendants
  • K042037M2A Magnum SystemBiomet, Inc. · 2004 · 3 generations on116descendants
  • K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 4 generations on74descendants
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 5 generations on73descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902365Modular Unipolar SystemHowmedica Corp.1991—
+1K960538Opteon UnipolarExactech, Inc.1996—
+2K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999—
+3K042037M2A Magnum SystemBiomet, Inc.2004—
+4K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH200613
+5K071723Zimmer Porolock Mis StemZimmer GmbH20082

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200110
200220
200410
200510
200640
200710
200820
200910
201130
201270
201390
201460
201570
2016110
201780
2018120
2019180
2020160
2021120
2022110
2023100
2024120
2025150
2026130
FIG. 1 — Lineage of K902365, 1991–2026Source: 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 KWL? 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 KWL device

  1. #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 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? (185)

See all 185

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

NumberDeviceApplicantDecidedDescendants
K960538Opteon UnipolarExactech, Inc.1996121
K063791Corin Unipolar Modular HeadCorin USA200763
K014226Unitrax Modular Unipolar SystemHowmedica Osteonics Corp.200218
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics201617

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, K960538 (Exactech, Inc., 1996) has gone furthest, with 121 descendants of its own.

How does its category compare?

All KWL devices

KWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWL

3in 2025

2007: 22008: 12011: 22012: 12015: 12018: 22019: 12020: 12022: 12024: 12025: 32026 (partial year): 2
2007high 3 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWL

32in 2025

2025: 32 days median
2007high 32 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWL

2in 2017

2007: 362009: 22015: 12017: 22026 (partial year): 1
2007high 36 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KWL

29in 2025

2007: 112008: 132009: 212010: 552011: 512012: 622013: 892014: 1072015: 2232016: 2102017: 3472018: 2942019: 4152020: 2702021: 1072022: 992023: 482024: 1432025: 29
2007high 415 (2019) · low 11 (2007)2025

MAUDE reports naming product code KWL, 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
20072—3611
20081—013
20090—221
20100—055
20112—051
20121—062
20130—089
20140—0107
20151—1223
20160—0210
20170—2347
20182—0294
20191—0415
20201—0270
20210—0107
20221—099
20230—048
20241—0143
2025332029
20262—1—

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 KWL

The KWL category page

  • K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC · 2026
  • K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UC · 2026
  • K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025
  • K252326InterSpace GV Hip SpacerTecres S.P.A. · 2025
  • K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd. · 2025

https://510kreport.com/device/K902365 · printed Nov 4, 2026

Cite this page

510(k) Report. “K902365: Modular Unipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K902365

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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