510(k) Report

510(k) · Cleared

Cleared

Unitrax V40 Modular Adaptor

K954077510(k) TraditionalCleared Nov 15, 199577-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 Nov 15, 1995 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 134 later devices descend from it.

Decided
Nov 15, 1995
Review
77 days
Class
Class II
Product code
KWL
Recalls
None
Predicates
0

134 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2016: 8 descendants cleared2018: 9 descendants cleared2019: 16 descendants cleared2022: 7 descendants cleared2020: 13 descendants cleared2021: 9 descendants cleared2023: 6 descendants cleared2004: 1 descendant cleared2012: 4 descendants cleared2006: 4 descendants cleared2008: 2 descendants cleared2013: 5 descendants cleared2011: 2 descendants cleared2026: 10 descendants cleared2025: 10 descendants cleared2024: 9 descendants cleared2009: 1 descendant cleared2015: 6 descendants cleared2017: 6 descendants cleared2014: 5 descendants cleared1995200020052010201520202025
  1. This deviceK954077 Unitrax V40 Modular AdaptorHowmedica Corp. · 1995
  2. Descendant · cites it directly · 117 of its ownK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
  3. Descendant · 2 generations on · 116 of its ownK042037 M2A Magnum SystemBiomet, Inc. · 2004
  4. Descendant · 3 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
  5. Descendant · 4 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  6. Descendant · 5 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled

Showing 5 of 134 descendants. See all descendants

Descendants cleared per year

1999: 12004: 12006: 42008: 22009: 12011: 22012: 42013: 52014: 52015: 62016: 82017: 62018: 92019: 162020: 132021: 92022: 72023: 62024: 92025: 102026: 10
1999high 16 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 134 · See all
  • K984028The New Bio-Moore Endo HeadsBiomet, Inc. · 1999 · cites it directly117descendants
  • K042037M2A Magnum SystemBiomet, Inc. · 2004 · 2 generations on116descendants
  • K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 3 generations on74descendants
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 4 generations on73descendants
  • K123392Avenir Muller StemZimmer GmbH · 2013 · 5 generations on41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954077Unitrax V40 Modular AdaptorHowmedica Corp.1995—
+1K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999—
+2K042037M2A Magnum SystemBiomet, Inc.2004—
+3K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH200613
+4K071723Zimmer Porolock Mis StemZimmer GmbH20082
+5K123392Avenir Muller StemZimmer GmbH20134

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200410
200640
200820
200910
201120
201240
201350
201450
201560
201680
201760
201890
2019160
2020130
202190
202270
202360
202490
2025100
2026100
FIG. 1 — Lineage of K954077, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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? (134)

See all 134

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

NumberDeviceApplicantDecidedDescendants
K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999117
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, K984028 (Biomet, Inc., 1999) has gone furthest, with 117 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/K954077 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954077: Unitrax V40 Modular Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954077

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026