510(k) Report

510(k) · Cleared

Cleared

Trident Large Diameter Acetabular Inserts

K062419510(k) TraditionalCleared Nov 15, 200689-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

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

Cleared on Nov 15, 2006 as substantially equivalent to K033716 (Howmedica Osteonics Corp., 2005) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 2000. 23 later devices descend from it.

Decided
Nov 15, 2006
Review
89 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K002575 (2000). 2 ancestors in all. 23 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2025: 5 descendants cleared2016: 1 descendant cleared2019: 3 descendants cleared2010: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2022: 4 descendants cleared2020: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant clearedK002575 · Inter-OP Durasul Acetabular Inserts (4MM) · Sulzer Orthopedics, Inc. · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants K002575 · Inter-OP Durasul Acetabular Inserts (4MM) · Sulzer Orthopedics, Inc. · 20000
  1. Root · 1 generation backK002575 Inter-OP Durasul Acetabular Inserts (4MM)Sulzer Orthopedics, Inc. · 2000
  2. This deviceK062419 Trident Large Diameter Acetabular InsertsHowmedica Osteonics Corp. · 2006
  3. Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
  4. Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  5. Descendant · cites it directly · 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 · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
  7. Descendant · 2 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2010: 12016: 12017: 12018: 12019: 32020: 22021: 12022: 42023: 12024: 22025: 52026: 1
2010high 5 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 23 · See all
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
  • K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · cites it directly7descendants
  • K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
  • K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002575Inter-OP Durasul Acetabular Inserts (4MM)Sulzer Orthopedics, Inc.2000—
0 (this device)K062419Trident Large Diameter Acetabular InsertsHowmedica Osteonics Corp.2006—
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics20161
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20182
+1K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.20201

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201610
201710
201810
201930
202020
202110
202240
202310
202420
202550
202610
FIG. 1 — Lineage of K062419, 2000–2026Source: 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), the FDA summary (predicates and indications), 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
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K033716Trident Acetabular System
Summary page 2
…acetabulum. Substantial Equivalence: The Trident® large diameter acetabular inserts are substantially equivalent to Howmedica Osteonics' Trident® Acetabular Inserts, K033716 and Inter-Op Durasul Acetabular System cleared by Sulzer Orthopaedics, K002575.…
Howmedica Osteonics Corp.20052
*K002575Inter-OP Durasul Acetabular Inserts (4MM)
Summary page 2
…inserts are substantially equivalent to Howmedica Osteonics' Trident® Acetabular Inserts, K033716 and Inter-Op Durasul Acetabular System cleared by Sulzer Orthopaedics, K002575. 4 DEPARTMENT OF HEALTH & HUMAN SERVICES…
Sulzer Orthopedics, Inc.2000—

Also cleared against K033716: 4 other devices →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics201617
K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197
K172651FMP Extended LinersEncore Medical L.P.20173
K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250
K103124Series II X3 Large Diameter Accetabular InsertsStryker Corporation20100

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 descendants of its own.
  • 4 other devices also cite its predicate K033716.

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—

What is it indicated for?

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,

Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,

Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,

Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

Indications for use as stated in the FDA summary.

Also cleared against K033716

4 other devices cite the same predicate.

  • K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
  • K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall
  • K061434Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 20062 recalls

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

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/K062419 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062419: Trident Large Diameter Acetabular Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062419

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026