510(k) Report

510(k) · Cleared

Recalled · 2008

Osteonics Omnifit AD-HA Hip Stem Series

K941366510(k) TraditionalCleared Jun 6, 1995442-day reviewClass II21 CFR 888.3353Recalls 1

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

Osteonics Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on Jun 6, 1995 after a 442-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 241 later devices descend from it. It has been recalled once.

Decided
Jun 6, 1995
Review
442 days
Class
Class II
Product code
MEH
Recalls
1
Predicates
0

241 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2000: 3 descendants cleared2004: 2 descendants cleared2016: 14 descendants cleared2002: 2 descendants cleared2006: 4 descendants cleared2012: 10 descendants cleared2005: 2 descendants cleared2011: 7 descendants cleared2018: 10 descendants cleared2001: 1 descendant cleared2021: 13 descendants cleared2020: 14 descendants cleared2009: 4 descendants cleared2017: 19 descendants cleared2019: 18 descendants cleared2013: 9 descendants cleared2014: 8 descendants cleared2015: 11 descendants cleared2026: 12 descendants cleared2023: 13 descendants cleared2025: 23 descendants cleared2024: 14 descendants cleared2022: 15 descendants cleared2008: 6 descendants cleared2003: 1 descendant cleared2010: 5 descendants cleared2007: 1 descendant cleared1995200020052010201520202025
  1. This deviceK941366 Osteonics Omnifit AD-HA Hip Stem SeriesOsteonics Corp. · 1995
  2. Descendant · cites it directly · 224 of its ownK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
  3. Descendant · 2 generations on · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
  4. Descendant · 2 generations on · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  5. Descendant · 3 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  6. Descendant · 4 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008

Showing 5 of 241 descendants. See all descendants

Descendants cleared per year

2000: 32001: 12002: 22003: 12004: 22005: 22006: 42007: 12008: 62009: 42010: 52011: 72012: 102013: 92014: 82015: 112016: 142017: 192018: 102019: 182020: 142021: 132022: 152023: 132024: 142025: 232026: 12
2000high 23 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 241 · See all
  • K993768Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · cites it directly224descendants
  • K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · 2 generations on150descendants
  • K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · 2 generations on101descendants
  • K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 3 generations on90descendants
  • K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 4 generations on83descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K941366Osteonics Omnifit AD-HA Hip Stem SeriesOsteonics Corp.1995—
+1K993768Citation TMZF HA StemHowmedica Osteonics Corp.200012
+2K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000—
+2K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
+3K060437Excia Total Hip System with U-CapAesculap, Inc.2006—
+4K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200030
200110
200220
200310
200420
200520
200640
200710
200860
200940
201050
201170
2012100
201390
201480
2015110
2016140
2017190
2018100
2019180
2020140
2021130
2022150
2023130
2024140
2025230
2026120
FIG. 1 — Lineage of K941366, 1995–2026Source: 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 MEH? 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 MEH device

  1. #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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? (241)

See all 241

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

NumberDeviceApplicantDecidedDescendants
K993768Citation TMZF HA StemHowmedica Osteonics Corp.2000224
K994366TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemHowmedica Osteonics Corp.200076
K041170Secur-Fit HA and Secur-Fit Plus Hip StemsHowmedica Osteonics Corp.200418

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 13, 2008Not classifiedZ-0902-2009PackagingStryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K993768 (Howmedica Osteonics Corp., 2000) has gone furthest, with 224 descendants of its own.

How does its category compare?

All MEH devices

MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEH

5in 2025

2007: 22008: 62009: 62010: 52011: 52012: 62013: 12015: 22016: 62017: 32018: 22019: 12020: 32021: 32022: 32023: 22024: 62025: 52026 (partial year): 1
2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEH

87in 2025

2008: 79 days median2009: 65 days median2010: 226 days median2011: 95 days median2012: 131 days median2016: 163 days median2017: 209 days median2020: 131 days median2021: 83 days median2022: 150 days median2024: 91 days median2025: 87 days median
2007high 226 (2010) · low 65 (2009)2026

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

Recalls per year · MEH

1in 2025

2007: 32008: 802009: 512010: 162011: 42012: 32014: 12015: 12016: 42017: 12018: 32020: 12025: 12026 (partial year): 1
2007high 80 (2008) · low 0 (2013)2026

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

Adverse event reports per year · MEH

470in 2025

2007: 252008: 2612009: 5392010: 4622011: 4192012: 1,6062013: 1,2952014: 1,1962015: 4902016: 3472017: 3832018: 3372019: 3352020: 3382021: 3722022: 3162023: 3342024: 3542025: 470
2007high 1,606 (2012) · low 25 (2007)2025

MAUDE reports naming product code MEH, 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—325
200867980261
200966551539
2010522616462
20115954419
2012613131,606
20131—01,295
20140—11,196
20152—1490
201661634347
201732091383
20182—3337
20191—0335
202031311338
20213830372
202231500316
20232—0334
20246910354
20255871470
20261—1—

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178 FDA decisions under this applicant name. See the company

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  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

Recent decisions in MEH

The MEH category page

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  • K251166Mfinity Femoral SystemMedacta International S.A. · 2025
  • K251052Trivicta® Hip StemOrtho Development Corp. · 2025
  • K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025

https://510kreport.com/device/K941366 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941366: Osteonics Omnifit AD-HA Hip Stem Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941366

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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