510(k) Report

510(k) · Cleared

Cleared

Osteonics Secur-Fit HA Plus Hip Stem Series

K951517510(k) TraditionalCleared Jan 17, 1996289-day reviewClass II21 CFR 888.3353

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 Jan 17, 1996 after a 289-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided
Jan 17, 1996
Review
289 days
Class
Class II
Product code
MEH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2019: 2 descendants cleared2022: 4 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2025: 4 descendants cleared2024: 2 descendants cleared1995200020052010201520202025
  1. This deviceK951517 Osteonics Secur-Fit HA Plus Hip Stem SeriesOsteonics Corp. · 1996
  2. Descendant · cites it directly · 18 of its ownK041170 Secur-Fit HA and Secur-Fit Plus Hip StemsHowmedica Osteonics Corp. · 2004 · Recalled
  3. Descendant · 2 generations on · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
  4. Descendant · 3 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  5. Descendant · 3 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
  6. Descendant · 3 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2004: 12016: 12018: 12019: 22020: 12021: 12022: 42023: 12024: 22025: 42026: 1
2004high 4 (2022) · low 0 (2005)2026

Most influential descendants

Showing 5 of 19 · See all
  • K041170Secur-Fit HA and Secur-Fit Plus Hip StemsHowmedica Osteonics Corp. · 2004 · cites it directly18descendants
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · 2 generations on17descendants
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 3 generations on8descendants
  • K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 3 generations on7descendants
  • K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951517Osteonics Secur-Fit HA Plus Hip Stem SeriesOsteonics Corp.1996—
+1K041170Secur-Fit HA and Secur-Fit Plus Hip StemsHowmedica Osteonics Corp.20042
+2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics20161
+3K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20182
+3K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019—
+3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201610
201810
201920
202010
202110
202240
202310
202420
202540
202610
FIG. 1 — Lineage of K951517, 1996–2026Source: 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? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K041170Secur-Fit HA and Secur-Fit Plus Hip StemsHowmedica Osteonics Corp.200418

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, K041170 (Howmedica Osteonics Corp., 2004) has gone furthest, with 18 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—

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 MEH

The MEH category page

  • K261576Icona Hip StemCorin, Ltd. · 2026
  • K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
  • 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/K951517 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951517: Osteonics Secur-Fit HA Plus 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/K951517

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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