510(k) Report

510(k) · Cleared

Cleared

Osteonics Omnifit AD Hip Stem Series

K940715510(k) TraditionalCleared Jun 7, 1995474-day reviewClass II21 CFR 888.3358

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

Osteonics Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jun 7, 1995 after a 474-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 210 later devices descend from it.

Decided
Jun 7, 1995
Review
474 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

210 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2003: 1 descendant cleared2012: 15 descendants cleared2005: 5 descendants cleared2006: 2 descendants cleared2011: 4 descendants cleared2007: 3 descendants cleared2019: 21 descendants cleared2008: 2 descendants cleared2014: 16 descendants cleared2013: 10 descendants cleared2016: 9 descendants cleared2010: 2 descendants cleared2015: 11 descendants cleared2017: 12 descendants cleared2009: 1 descendant cleared2025: 16 descendants cleared2026: 17 descendants cleared2020: 8 descendants cleared2023: 14 descendants cleared2024: 13 descendants cleared2018: 7 descendants cleared2022: 12 descendants cleared2021: 8 descendants cleared1995200020052010201520202025
  1. This deviceK940715 Osteonics Omnifit AD Hip Stem SeriesOsteonics Corp. · 1995
  2. Descendant · cites it directly · 209 of its ownK984408 130 Modified Integral Femoral ComponentBiomet, Inc. · 1999
  3. Descendant · 2 generations on · 208 of its ownK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
  4. Descendant · 3 generations on · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
  5. Descendant · 3 generations on · 138 of its ownK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
  6. Descendant · 4 generations on · 137 of its ownK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled

Showing 5 of 210 descendants. See all descendants

Descendants cleared per year

1999: 12003: 12005: 52006: 22007: 32008: 22009: 12010: 22011: 42012: 152013: 102014: 162015: 112016: 92017: 122018: 72019: 212020: 82021: 82022: 122023: 142024: 132025: 162026: 17
1999high 21 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 210 · See all
  • K984408130 Modified Integral Femoral ComponentBiomet, Inc. · 1999 · cites it directly209descendants
  • K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Biomet, Inc. · 2003 · 2 generations on208descendants
  • K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · 3 generations on160descendants
  • K050124Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · 3 generations on138descendants
  • K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · 4 generations on137descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940715Osteonics Omnifit AD Hip Stem SeriesOsteonics Corp.1995—
+1K984408130 Modified Integral Femoral ComponentBiomet, Inc.1999—
+2K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric…Biomet, Inc.20033
+3K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005—
+3K050124Porous Coated Acetabular ComponentsBiomet, Inc.20051
+4K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc.200719

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
200550
200620
200730
200820
200910
201020
201140
2012150
2013100
2014160
2015110
201690
2017120
201870
2019210
202080
202180
2022120
2023140
2024130
2025160
2026170
FIG. 1 — Lineage of K940715, 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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (210)

See all 210

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K984408130 Modified Integral Femoral ComponentBiomet, Inc.1999209

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, K984408 (Biomet, Inc., 1999) has gone furthest, with 209 descendants of its own.

How does its category compare?

All LPH devices

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

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K940715 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940715: Osteonics Omnifit AD 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/K940715

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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