510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Stryker Orthopaedics Hip Systems Labeling Update

K153345510(k) TraditionalCleared May 25, 2016188-day reviewClass II21 CFR 888.3358Recalls 1

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

Stryker Orthopaedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on May 25, 2016 as substantially equivalent to K011623 (Howmedica Osteonics Corp., 2001) and 62 other predicates after a 188-day review. Its family tree reaches back 8 generations to 1994. 17 later devices descend from it. It has been recalled once.

Decided
May 25, 2016
Review
188 days
Class
Class II
Product code
LPH
Recalls
1
Predicates
63

Its longest line of descent runs back 8 generations to K921308 (1994). 117 ancestors in all, the oldest K894124 (1989). 17 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2014: 1 other ancestor2013: 1 other ancestor2012: 1 other ancestor2011: 4 other ancestors2009: 2 other ancestors2008: 1 other ancestor2007: 2 other ancestors2006: 4 other ancestors2005: 7 other ancestors2004: 3 other ancestors2003: 5 other ancestors2002: 11 other ancestors2001: 6 other ancestors2000: 11 other ancestors1999: 5 other ancestors1998: 7 other ancestors1997: 6 other ancestors1995: 9 other ancestors1994: 7 other ancestors1992: 2 other ancestors1991: 4 other ancestors1990: 2 other ancestors1989: 1 other ancestor1996: 6 other ancestors2018: 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 clearedK921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK103479 · Novel Tapered Hip Stem · Stryker Corp. · 2011K120578 · Accolade II Hip Stem · Howmedica Osteonics · 2012 · recalledK122853 · Novel Fit and Fill Stem · Howmedica Osteonics Corp. · 2013K143085 · Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach · Stryker Orthopaedics · 2015 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 59 other ancestors2 generations back: 28 other ancestors3 generations back: 15 other ancestors4 generations back: 7 other ancestors 1 generation forward: 8 descendants2 generations forward: 9 descendants K143085 · Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach · Stryker Orthopaedics · 2015 · recalledK122853 · Novel Fit and Fill Stem · Howmedica Osteonics Corp. · 2013K120578 · Accolade II Hip Stem · Howmedica Osteonics · 2012 · recalledK103479 · Novel Tapered Hip Stem · Stryker Corp. · 2011K013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalled−50
  1. Root · 8 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
  2. 7 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
  3. 6 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
  4. 5 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  5. 4 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
  6. 3 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
  7. 2 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
  8. 1 generation backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
  9. This deviceK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016
  10. Descendant · cites it directly · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  11. 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
  12. Descendant · cites it directly · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
  13. Descendant · cites it directly · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
  14. Descendant · cites it directly · 5 of its ownK222632 UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2018: 12019: 22020: 12021: 12022: 42023: 12024: 22025: 42026: 1
2018high 4 (2022) · low 1 (2018)2026

Most influential descendants

Showing 5 of 17 · See all
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · cites it directly8descendants
  • 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 · cites it directly6descendants
  • K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · cites it directly6descendants
  • K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K921308HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc.19941
−7K972893Partnership Revision Femoral StemsHowmedica Corp.1997—
−6K983404Type 3 Femoral ComponentsHowmedica Corp.19981
−5K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
−4K103479Novel Tapered Hip StemStryker Corp.2011—
−3K120578Accolade II Hip StemHowmedica Osteonics20121
−2K122853Novel Fit and Fill StemHowmedica Osteonics Corp.2013—
−1K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics20152
0 (this device)K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016—
+1K173499Exeter 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—
+1K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022—
+1K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.20201
+1K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199020
199140
199220
199470
199590
199660
199760
199870
199950
2000110
200160
2002110
200350
200430
200570
200640
200720
200810
200920
201140
201210
201310
201410
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201920
202010
202110
202240
202310
202420
202540
202610
FIG. 1 — Lineage of K153345, 1994–2026Source: 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 24.3 · 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? (64)

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
*K011623Exeter Hip System with V40 Taper
Summary page 32
…HWC - screw, fixation, bone Legally Marketed Device to Which Substantial Equivalence is Claimed: Femoral Stems Exeter Femoral Stems (V40 taper – K011623, K031730, K110290, includes Orthinox femoral heads) K121308 SecurFit Max Femoral Stems K041170, K051738 Se…
Howmedica Osteonics Corp.2001—
*K03173036MM Orthinox V40 Femoral Head Components
Summary page 32
…HWC - screw, fixation, bone Legally Marketed Device to Which Substantial Equivalence is Claimed: Femoral Stems Exeter Femoral Stems (V40 taper – K011623, K031730, K110290, includes Orthinox femoral heads) K121308 SecurFit Max Femoral Stems K041170, K051738 SecurFit Ma…
Howmedica Osteonics Corp.2003—
*K110290Exeter Hip Stem
Summary page 32
…- screw, fixation, bone Legally Marketed Device to Which Substantial Equivalence is Claimed: Femoral Stems Exeter Femoral Stems (V40 taper – K011623, K031730, K110290, includes Orthinox femoral heads) K121308 SecurFit Max Femoral Stems K041170, K051738 SecurFit Max Plus Fe…
Howmedica Osteonics Corp.20111
*K121308Hip Systems
Summary page 32
…to Which Substantial Equivalence is Claimed: Femoral Stems Exeter Femoral Stems (V40 taper – K011623, K031730, K110290, includes Orthinox femoral heads) K121308 SecurFit Max Femoral Stems K041170, K051738 SecurFit Max Plus Femoral Stems Accolade C Femoral Stems…
Howmedica Osteonics Corp.20127
*K041170Secur-Fit HA and Secur-Fit Plus Hip Stems
Summary page 32
…oral Stems Exeter Femoral Stems (V40 taper – K011623, K031730, K110290, includes Orthinox femoral heads) K121308 SecurFit Max Femoral Stems K041170, K051738 SecurFit Max Plus Femoral Stems Accolade C Femoral Stems K022555, K121308 Accolade TMZF Femoral Stems…
Howmedica Osteonics Corp.20042
*K051738Secur-Fit Max and Plus Max Hip Stems
Summary page 32
…s Exeter Femoral Stems (V40 taper – K011623, K031730, K110290, includes Orthinox femoral heads) K121308 SecurFit Max Femoral Stems K041170, K051738 SecurFit Max Plus Femoral Stems Accolade C Femoral Stems K022555, K121308 Accolade TMZF Femoral Stems…
Howmedica Osteonics Corp.2005—
*K022555Accolade C Femoral Stems
Summary page 32
…thinox femoral heads) K121308 SecurFit Max Femoral Stems K041170, K051738 SecurFit Max Plus Femoral Stems Accolade C Femoral Stems K022555, K121308 Accolade TMZF Femoral Stems K994366, K020572 Accolade TMZF Plus Femoral Stem K994366, K023102 Acco…
Howmedica Osteonics Corp.20026
*K994366TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem
Summary page 32
…l Stems K041170, K051738 SecurFit Max Plus Femoral Stems Accolade C Femoral Stems K022555, K121308 Accolade TMZF Femoral Stems K994366, K020572 Accolade TMZF Plus Femoral Stem K994366, K023102 Accolade HFx Femoral Stem K051741, K121308 Acco…
Howmedica Osteonics Corp.20003
*K020572Accolade TMZF HA 132 Degree Size 0 Hip Stem
Summary page 32
…K041170, K051738 SecurFit Max Plus Femoral Stems Accolade C Femoral Stems K022555, K121308 Accolade TMZF Femoral Stems K994366, K020572 Accolade TMZF Plus Femoral Stem K994366, K023102 Accolade HFx Femoral Stem K051741, K121308 Accolade II F…
Howmedica Osteonics Corp.200211
*K023102Accolade TMZF Plus HA 127 Size 0 Hip Stem
Summary page 32
…ems Accolade C Femoral Stems K022555, K121308 Accolade TMZF Femoral Stems K994366, K020572 Accolade TMZF Plus Femoral Stem K994366, K023102 Accolade HFx Femoral Stem K051741, K121308 Accolade II Femoral Stems K103479, K120578, K143085 Secu…
Howmedica Osteonics Corp.200213
*K051741Accolade HFX Femoral Stem
Summary page 32
…555, K121308 Accolade TMZF Femoral Stems K994366, K020572 Accolade TMZF Plus Femoral Stem K994366, K023102 Accolade HFx Femoral Stem K051741, K121308 Accolade II Femoral Stems K103479, K120578, K143085 SecurFit Advanced Femoral Stems K122853, K14…
Stryker Orthopaedics2005—
*K103479Novel Tapered Hip Stem
Summary page 32
…366, K020572 Accolade TMZF Plus Femoral Stem K994366, K023102 Accolade HFx Femoral Stem K051741, K121308 Accolade II Femoral Stems K103479, K120578, K143085 SecurFit Advanced Femoral Stems K122853, K143085 Anato Femoral Stems K123604, K14…
Stryker Corp.2011—
*K120578Accolade II Hip Stem
Summary page 32
…572 Accolade TMZF Plus Femoral Stem K994366, K023102 Accolade HFx Femoral Stem K051741, K121308 Accolade II Femoral Stems K103479, K120578, K143085 SecurFit Advanced Femoral Stems K122853, K143085 Anato Femoral Stems K123604, K143085 Omni…
Howmedica Osteonics20121
*K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…
Summary page 32
…ade TMZF Plus Femoral Stem K994366, K023102 Accolade HFx Femoral Stem K051741, K121308 Accolade II Femoral Stems K103479, K120578, K143085 SecurFit Advanced Femoral Stems K122853, K143085 Anato Femoral Stems K123604, K143085 OmniFit HFx F…
Stryker Orthopaedics20152
*K122853Novel Fit and Fill Stem
Summary page 32
…102 Accolade HFx Femoral Stem K051741, K121308 Accolade II Femoral Stems K103479, K120578, K143085 SecurFit Advanced Femoral Stems K122853, K143085 Anato Femoral Stems K123604, K143085 OmniFit HFx Femoral Stems K031744 OmniFit EON F…
Howmedica Osteonics Corp.2013—
*K123604Abg Iii Monolithic Hip Stem
Summary page 32
…308 Accolade II Femoral Stems K103479, K120578, K143085 SecurFit Advanced Femoral Stems K122853, K143085 Anato Femoral Stems K123604, K143085 OmniFit HFx Femoral Stems K031744 OmniFit EON Femoral Stems K983226 Acetabular Shells/Augm…
Howmedica Osteonics Corp.20131
*K031744Omnifit HFX Hip Stem Series
Summary page 32
…578, K143085 SecurFit Advanced Femoral Stems K122853, K143085 Anato Femoral Stems K123604, K143085 OmniFit HFx Femoral Stems K031744 OmniFit EON Femoral Stems K983226 Acetabular Shells/Augments/Plug Trident Hemispherical Shells (multiple K013676…
Howmedica Osteonics Corp.20031
*K983226Osteonics X Cemented Hip Stem Series
Summary page 32
…K122853, K143085 Anato Femoral Stems K123604, K143085 OmniFit HFx Femoral Stems K031744 OmniFit EON Femoral Stems K983226 Acetabular Shells/Augments/Plug Trident Hemispherical Shells (multiple K013676, K143085 configurations) Tritanium Shells (multi…
Osteonics Corp.19982
*K013676Trident Hemispherical Acetabular Shells
Summary page 32
…mniFit HFx Femoral Stems K031744 OmniFit EON Femoral Stems K983226 Acetabular Shells/Augments/Plug Trident Hemispherical Shells (multiple K013676, K143085 configurations) Tritanium Shells (multiple styles) K081171, K143085…
Howmedica Osteonics Corp.20018
*K081171Tritanium Acetabular Shell System
Summary page 32
…K983226 Acetabular Shells/Augments/Plug Trident Hemispherical Shells (multiple K013676, K143085 configurations) Tritanium Shells (multiple styles) K081171, K143085 Page 3 of 15…
Howmedica Osteonics Corp.2008—
*K142462Restoration Anatomic Shell
Summary page 33
…3 of 15 K153345 Pg.3/14 Restoration Anatomic Acetabular Shell K142462, K151264 Tritanium Multi-Hole Shell K010170, K143085 Trident AD Acetabular Shell (multiple K983502 styles)…
Stryker Orthopaedics2014—
*K151264Restoration Anatomic Shell
Summary page 33
…K153345 Pg.3/14 Restoration Anatomic Acetabular Shell K142462, K151264 Tritanium Multi-Hole Shell K010170, K143085 Trident AD Acetabular Shell (multiple K983502 styles) Trident…
Stryker Orthopaedics201517
*K010170Trident Porous Titanium Acetabular Component
Summary page 33
…K153345 Pg.3/14 Restoration Anatomic Acetabular Shell K142462, K151264 Tritanium Multi-Hole Shell K010170, K143085 Trident AD Acetabular Shell (multiple K983502 styles) Trident HA PSL Shell (multiple styles) K983382, K143085…
Howmedica Osteonics Corp.2001—
*K983502Osteonics Secur-Fit AD Generation II Acetabular Component System
Summary page 33
…Restoration Anatomic Acetabular Shell K142462, K151264 Tritanium Multi-Hole Shell K010170, K143085 Trident AD Acetabular Shell (multiple K983502 styles) Trident HA PSL Shell (multiple styles) K983382, K143085 Trident T Shell K040412 Restorat…
Osteonics Corp.19981
*K983382Osteonics HA Generation II Acetabular Component System
Summary page 33
…1264 Tritanium Multi-Hole Shell K010170, K143085 Trident AD Acetabular Shell (multiple K983502 styles) Trident HA PSL Shell (multiple styles) K983382, K143085 Trident T Shell K040412 Restoration ADM Acetabular Shell K072020 Restoration Acet…
Osteonics Corp.19984
*K040412Trident T Acetabular Shells
Summary page 33
…3085 Trident AD Acetabular Shell (multiple K983502 styles) Trident HA PSL Shell (multiple styles) K983382, K143085 Trident T Shell K040412 Restoration ADM Acetabular Shell K072020 Restoration Acetabular Augments K102019 Acetabular Dome Hole Plug…
Stryker Orthopaedics2004—
*K072020Restoration Adm System
Summary page 33
…3502 styles) Trident HA PSL Shell (multiple styles) K983382, K143085 Trident T Shell K040412 Restoration ADM Acetabular Shell K072020 Restoration Acetabular Augments K102019 Acetabular Dome Hole Plug K920868…
Howmedica Osteonics Corp.20071
*K102019Restoration Acetabular Wedge Augments
Summary page 33
…K983382, K143085 Trident T Shell K040412 Restoration ADM Acetabular Shell K072020 Restoration Acetabular Augments K102019 Acetabular Dome Hole Plug K920868 K942809 Acetabular Liners MDM Li…
Howmedica Osteonics20111
*K920868Acetabular Dome and Screw Hole Plugs
Summary page 33
…K040412 Restoration ADM Acetabular Shell K072020 Restoration Acetabular Augments K102019 Acetabular Dome Hole Plug K920868 K942809 Acetabular Liners MDM Liners K103233 ADM/MD…
Osteonics Corp.1992—
*K942809Acetabular Dome Hole Plugs
Summary page 33
…ll K072020 Restoration Acetabular Augments K102019 Acetabular Dome Hole Plug K920868 K942809 Acetabular Liners MDM Liners K103233 ADM/MDM X3 inserts K093644 ADM/MD…
Osteonics Corp.1994—
*K103233Modular Dual Mobility Liner, X3 Acetabular Insert
Summary page 33
…19 Acetabular Dome Hole Plug K920868 K942809 Acetabular Liners MDM Liners K103233 ADM/MDM X3 inserts K093644 ADM/MDM Duration Inserts, OD 42mm- K072020 52mm Trident X3 Liners (m…
Howmedica Osteonics Corp.20111
*K093644Restoration Adm System X3 Acetabular
Summary page 33
…68 K942809 Acetabular Liners MDM Liners K103233 ADM/MDM X3 inserts K093644 ADM/MDM Duration Inserts, OD 42mm- K072020 52mm Trident X3 Liners (multiple sizes) K033716…
Howmedica Osteonics Corp.20091
*K033716Trident Acetabular System
Summary page 33
…K103233 ADM/MDM X3 inserts K093644 ADM/MDM Duration Inserts, OD 42mm- K072020 52mm Trident X3 Liners (multiple sizes) K033716 K061434 K062419 Trident Crossfire Liners…
Howmedica Osteonics Corp.20052
*K061434Trident Large Diameter Hip System
Summary page 33
…K093644 ADM/MDM Duration Inserts, OD 42mm- K072020 52mm Trident X3 Liners (multiple sizes) K033716 K061434 K062419 Trident Crossfire Liners (multiple sizes) K983502…
Howmedica Osteonics Corp.20062
*K062419Trident Large Diameter Acetabular Inserts
Summary page 33
…K072020 52mm Trident X3 Liners (multiple sizes) K033716 K061434 K062419 Trident Crossfire Liners (multiple sizes) K983502 K991952…
Howmedica Osteonics Corp.2006—
*K991952Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts
Summary page 33
…K061434 K062419 Trident Crossfire Liners (multiple sizes) K983502 K991952 K021911 K020497 Trident Constrained Liner…
Howmedica Osteonics Corp.1999—
*K021911Trident Crossfire Polyuethylene Liners
Summary page 33
…K062419 Trident Crossfire Liners (multiple sizes) K983502 K991952 K021911 K020497 Trident Constrained Liner K061654 Trident All Polyethylene…
Howmedica Osteonics Corp.2002—
*K020497Trident Elevated Rim Liner
Summary page 33
…iple sizes) K983502 K991952 K021911 K020497 Trident Constrained Liner K061654 Trident All Polyethylene Constrained Liner Trident 10 degree Constrained Line…
Howmedica Osteonics Corp.2002—
*K061654Trident Constrained Acetabular Insert
Summary page 33
…K991952 K021911 K020497 Trident Constrained Liner K061654 Trident All Polyethylene Constrained Liner Trident 10 degree Constrained Liner P960047 Trident Liners N2/Vac(multiple siz…
Howmedica Osteonics Corp.2006—
*P960047Osteonics Constrained Acetabular Insert
Summary page 33
…K020497 Trident Constrained Liner K061654 Trident All Polyethylene Constrained Liner Trident 10 degree Constrained Liner P960047 Trident Liners N2/Vac(multiple sizes) K983502 Femoral heads and Adapter Sleeves BIOLOX Delta Heads (Various sizes,…
Howmedica Osteonics Corp.1997—
*K052718V40 Biolox Delta Ceramic Femoral Heads
Summary page 33
…egree Constrained Liner P960047 Trident Liners N2/Vac(multiple sizes) K983502 Femoral heads and Adapter Sleeves BIOLOX Delta Heads (Various sizes, K052718 styles) K070885 K041940…
Howmedica Osteonics Corp.20052
*K070885Universal Taper Delta Femoral Head
Summary page 33
…rs N2/Vac(multiple sizes) K983502 Femoral heads and Adapter Sleeves BIOLOX Delta Heads (Various sizes, K052718 styles) K070885 K041940 K051588 Co Cr Heads (various styl…
Howmedica Osteonics Corp.2007—
*K041940Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads
Summary page 33
…s and Adapter Sleeves BIOLOX Delta Heads (Various sizes, K052718 styles) K070885 K041940 K051588 Co Cr Heads (various styles/sizes) K993601…
Howmedica Osteonics Corp.2005—
*K051588Biolox Delta Ceramic Femoral Heads
Summary page 33
…zes, K052718 styles) K070885 K041940 K051588 Co Cr Heads (various styles/sizes) K993601 K010757, K022077, K061434…
Howmedica Osteonics Corp.2005—
*K993601Howmedica Osteonics Femoral Heads
Summary page 33
…K070885 K041940 K051588 Co Cr Heads (various styles/sizes) K993601 K010757, K022077, K061434 K900836, K99360…
Howmedica Osteonics Corp.19993
*K010757Lfit V40 Femoral Head Components
Summary page 33
…K041940 K051588 Co Cr Heads (various styles/sizes) K993601 K010757, K022077, K061434 K900836, K993601, K021310…
Howmedica Osteonics Corp.20014
*K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)
Summary page 33
…K041940 K051588 Co Cr Heads (various styles/sizes) K993601 K010757, K022077, K061434 K900836, K993601, K021310 K91098…
Howmedica Osteonics Corp.200212
*K900836Osteonics Ecsi Hip Stem Series
Summary page 33
…588 Co Cr Heads (various styles/sizes) K993601 K010757, K022077, K061434 K900836, K993601, K021310 K910988, K061434 K12130…
Osteonics Corp.1990—
*K02131036MM C-Taper Femoral Head Components (Lfit and Non-Lfit)
Summary page 33
…arious styles/sizes) K993601 K010757, K022077, K061434 K900836, K993601, K021310 K910988, K061434 K121308 Alumina C-Taper…
Howmedica Osteonics Corp.2002—
*K910988Osteonics Ion Implanted Femoral Bearing Series
Summary page 33
…K010757, K022077, K061434 K900836, K993601, K021310 K910988, K061434 K121308 Alumina C-Taper and V40 Heads K023901, K971409 (variou…
Osteonics Corp.1991—
*K023901Alumina V40 Femoral Heads
Summary page 33
…601, K021310 K910988, K061434 K121308 Alumina C-Taper and V40 Heads K023901, K971409 (various sizes) K003391, K991952 Unitrax Endo Head (38, 40-56, 58, 61) K902365, K014…
Howmedica Osteonics Corp.2003—
*K971409Osteonics Alumina C-Taper Head
Summary page 33
…310 K910988, K061434 K121308 Alumina C-Taper and V40 Heads K023901, K971409 (various sizes) K003391, K991952 Unitrax Endo Head (38, 40-56, 58, 61) K902365, K014226 Unitr…
Osteonics Corp.1997—
*K003391Osteonics Alumina C-Taper Head
Summary page 33
…988, K061434 K121308 Alumina C-Taper and V40 Heads K023901, K971409 (various sizes) K003391, K991952 Unitrax Endo Head (38, 40-56, 58, 61) K902365, K014226 Unitrax V40 Adapter Sleeve K954077, K992…
Howmedica Osteonics Corp.2000—
*K902365Modular Unipolar System
Summary page 33
…8 Alumina C-Taper and V40 Heads K023901, K971409 (various sizes) K003391, K991952 Unitrax Endo Head (38, 40-56, 58, 61) K902365, K014226 Unitrax V40 Adapter Sleeve K954077, K992570 Unitrax C-Taper Adapter Sleeve K121308 Adapter…
Howmedica Corp.1991—
*K014226Unitrax Modular Unipolar System
Summary page 33
…C-Taper and V40 Heads K023901, K971409 (various sizes) K003391, K991952 Unitrax Endo Head (38, 40-56, 58, 61) K902365, K014226 Unitrax V40 Adapter Sleeve K954077, K992570 Unitrax C-Taper Adapter Sleeve K121308 Adapter Sleeves…
Howmedica Osteonics Corp.20023
*K954077Unitrax V40 Modular Adaptor
Summary page 33
…9 (various sizes) K003391, K991952 Unitrax Endo Head (38, 40-56, 58, 61) K902365, K014226 Unitrax V40 Adapter Sleeve K954077, K992570 Unitrax C-Taper Adapter Sleeve K121308 Adapter Sleeves (various styles) K003379…
Howmedica Corp.1995—
*K992570Unitrax C-Taper Neck Adjustment Sleeve
Summary page 33
…s sizes) K003391, K991952 Unitrax Endo Head (38, 40-56, 58, 61) K902365, K014226 Unitrax V40 Adapter Sleeve K954077, K992570 Unitrax C-Taper Adapter Sleeve K121308 Adapter Sleeves (various styles) K003379…
Howmedica Osteonics Corp.1999—
*K003379V-40/C-Taper Adapter Sleeve
Summary page 33
…365, K014226 Unitrax V40 Adapter Sleeve K954077, K992570 Unitrax C-Taper Adapter Sleeve K121308 Adapter Sleeves (various styles) K003379 K051737 K070885 Bone Screws and Distal Sp…
Howmedica Osteonics Corp.2000—
*K051737Modification to V-40/C-Taper Adapter Sleeve
Summary page 33
…K954077, K992570 Unitrax C-Taper Adapter Sleeve K121308 Adapter Sleeves (various styles) K003379 K051737 K070885 Bone Screws and Distal Spacer Torx Screws K89…
Howmedica Osteonics Corp.2005—
*K894124Omnifit Self Tapping Cancellous Bone Screws
Summary page 33
…K051737 K070885 Bone Screws and Distal Spacer Torx Screws K894124 Page 4 of 15…
Osteonics Corp.19894
*K943549Restoration Acetabular Cup
Summary page 34
…== Page 34 === K153345 Pg.4/14 GAP Plate Screws K943549 Osteolock Bone Screws K903362 Universal Distal Spacer K914406 Device Description:…
Osteonics Corp.1994—
*K903362Osteolock (TM) Acetabular Cup
Summary page 34
…K153345 Pg.4/14 GAP Plate Screws K943549 Osteolock Bone Screws K903362 Universal Distal Spacer K914406 Device Description: All of the subject devices have been found substantial…
Howmedica Corp.1990—
*K914406PT II Distal Cement Spacer
Summary page 34
…Pg.4/14 GAP Plate Screws K943549 Osteolock Bone Screws K903362 Universal Distal Spacer K914406 Device Description: All of the subject devices have been found substantially equivalent in previous premarket indications. The p…
Osteonics Corp.1991—
*—Trident All Polyethylene Constrained Liner
Named without a submission number
—

Also cleared against K011623: 8 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20188
K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197
K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226
K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.20206
K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225
K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225
K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215
K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 18, 2016Class IIZ-0060-2017Nonconforming Material/ComponentStryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
  • 42 of the 117 ancestors have a recall of any class.
  • Of its descendants, K173499 (Stryker Orthopaedics, 2018) has gone furthest, with 8 descendants of its own.
  • 8 other devices also cite its predicate K011623.

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. 2016, this device’s year, is highlighted.

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?

The document contains multiple Indications for Use forms, one for each device or device group. Their statements are reproduced in the document text.

Indications for use as stated in the FDA summary.

Also cleared against K011623

8 other devices cite the same predicate.

  • K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 20201 recall
  • K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. · 2017
  • K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone PlugCorentec Co., Ltd. · 20161 recall
  • K142761Corin TaperFit Hip StemCorin USA · 20151 recall

More from Stryker Orthopaedics

24 FDA decisions under this applicant name. See the company

  • K211703Insignia Hip StemStryker Orthopaedics · 2021
  • K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall

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/K153345 · printed Nov 4, 2026

Cite this page

510(k) Report. “K153345: Stryker Orthopaedics Hip Systems Labeling Update.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153345

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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