510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component

K261624510(k) TraditionalCleared Jul 10, 202656-day reviewClass II21 CFR 888.3358Recalls 2

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

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

Cleared on Jul 10, 2026 as substantially equivalent to K243784 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2025) and 18 other predicates after a 56-day review. Its family tree reaches back 22 generations to 1994. It has been recalled 2 times.

Decided
Jul 10, 2026
Review
56 days
Class
Class II
Product code
LPH
Recalls
2
Predicates
19

Its longest line of descent runs back 22 generations to K941847 (1994). 328 ancestors in all, the oldest K800207 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 5 other ancestors2018: 1 other ancestor2012: 3 other ancestors2006: 8 other ancestors2002: 22 other ancestors1999: 9 other ancestors1998: 16 other ancestors1995: 22 other ancestors1991: 7 other ancestors1990: 6 other ancestors1989: 3 other ancestors1980: 1 other ancestor2021: 2 other ancestors2020: 2 other ancestors2019: 3 other ancestors2017: 1 other ancestor2016: 3 other ancestors2014: 2 other ancestors2013: 3 other ancestors2011: 10 other ancestors2005: 13 other ancestors2003: 13 other ancestors2001: 14 other ancestors1997: 15 other ancestors1993: 5 other ancestors2015: 2 other ancestors2009: 4 other ancestors2008: 4 other ancestors2007: 6 other ancestors2004: 10 other ancestors2000: 24 other ancestors1996: 20 other ancestors1994: 27 other ancestors1992: 7 other ancestors1988: 1 other ancestor1985: 3 other ancestors1987: 3 other ancestors2010: 3 other ancestors1984: 1 other ancestor1981: 1 other ancestorK941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994K964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalled×2: 2 generations cleared close together, K060918 (2006), K062684 (2006) ×2: 2 generations cleared close together, K082991 (2008), K083495 (2009) K090845 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2010 · recalledK111193 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2011K113242 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2012K123991 · Depuy Corail Amt Hip Prosthesis · Depuy France S.A.S. · 2013 · recalledK150862 · DePuy Actis Duofox Hip Prosthesis · DePuy Orthopaedics, Inc. · 2015 · recalledK170339 · Summit Hip System · DePuy Orthopaedics, Inc. · 2018K193398 · Summit DuoFix HA Coating · DePuy Orthopaedics, Inc. · 2020K202472 · ACTIS Duofix Hip Prosthesis · DePuy Orthopaedics, Inc. · 2020K211703 · Insignia Hip Stem · Stryker Orthopaedics · 2021K220731 · Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem · Stryker · 2022K233498 · Stryker Orthopaedics Hip Systems Labeling Update · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023K243784 · Stryker Orthopaedics Hip Devices Labeling Update · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 202519801990200020102020
Other ancestors, by generation 1 generation back: 17 other ancestors2 generations back: 27 other ancestors3 generations back: 68 other ancestors4 generations back: 44 other ancestors5 generations back: 14 other ancestors6 generations back: 11 other ancestors7 generations back: 17 other ancestors8 generations back: 18 other ancestors9 generations back: 17 other ancestors10 generations back: 22 other ancestors11 generations back: 21 other ancestors12 generations back: 12 other ancestors13 generations back: 7 other ancestors14 generations back: 7 other ancestors15 generations back: 3 other ancestors K243784 · Stryker Orthopaedics Hip Devices Labeling Update · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025K233498 · Stryker Orthopaedics Hip Systems Labeling Update · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023K220731 · Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem · Stryker · 2022K211703 · Insignia Hip Stem · Stryker Orthopaedics · 2021K202472 · ACTIS Duofix Hip Prosthesis · DePuy Orthopaedics, Inc. · 2020K193398 · Summit DuoFix HA Coating · DePuy Orthopaedics, Inc. · 2020K170339 · Summit Hip System · DePuy Orthopaedics, Inc. · 2018K150862 · DePuy Actis Duofox Hip Prosthesis · DePuy Orthopaedics, Inc. · 2015 · recalledK123991 · Depuy Corail Amt Hip Prosthesis · Depuy France S.A.S. · 2013 · recalledK113242 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2012K111193 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2011K090845 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2010 · recalledK083495 · Modification to: Metha Hip System · Aesculap Implant Systems, Inc. · 2009K082991 · Biolox Delta Ceramic Femoral Head · Aesculap Implant Systems, Inc. · 2008K062684 · Excia Total Hip System 36MM Ceramic Head · Aesculap, Inc. · 2006K060918 · Excia Total Hip System 12/14 Trunnion with Ceramic Head · Aesculap, Inc. · 2006K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994−20−15−10−50
  1. Root · 22 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 18 generations between
  3. 3 generations backK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
  4. 2 generations backK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  5. 1 generation backK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  6. This deviceK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026
Show all 22 generations
  1. Root · 22 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 21 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
  3. 20 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
  4. 19 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
  5. 18 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
  6. 17 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  7. 16 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
  8. 15 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
  9. 14 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
  10. 13 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
  11. 12 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
  12. 11 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
  13. 10 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
  14. 9 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
  15. 8 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
  16. 7 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
  17. 6 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
  18. 5 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
  19. 4 generations backK211703 Insignia Hip StemStryker Orthopaedics · 2021
  20. 3 generations backK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
  21. 2 generations backK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  22. 1 generation backK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  23. This deviceK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−22K9418475/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc.1994—
−21K964650TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc.1997—
−20K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.19981
−19K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc.2000—
−18K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003—
−17K042344Excia Total Hip SystemAesculap, Inc.200510
−16K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.2006—
−15K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.2006—
−14K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.2008—
−13K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.2009—
−12K090845Apex Arc Hip StemOmni Life Science, Inc.20102
−11K111193Apex Arc Hip StemOmni Life Science, Inc.2011—
−10K113242Apex Arc Hip StemOmni Life Science, Inc.2012—
−9K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.20131
−8K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.20151
−7K170339Summit Hip SystemDePuy Orthopaedics, Inc.2018—
−6K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.2020—
−5K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.2020—
−4K211703Insignia Hip StemStryker Orthopaedics2021—
−3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022—
−2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023—
−1K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
0 (this device)K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198110
198410
198530
198730
198810
198930
199060
199170
199270
199350
1994270
1995220
1996200
1997150
1998160
199990
2000240
2001140
2002220
2003130
2004100
2005130
200680
200760
200840
200940
201030
2011100
201230
201330
201420
201520
201630
201710
201810
201930
202020
202120
202250
FIG. 1 — Lineage of K261624, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (19)

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
*K243784Stryker Orthopaedics Hip Devices Labeling Update
Summary page 7
…H, KWL, LWJ, LZO, MEH, KWZ, JDI, LZN Legally Marketed Primary Predicate Device to Which Substantial Equivalence is Claimed: The primary predicate for this submission is K243784 Legally Marketed Additional Predicate Device Used to Support Substantial Equivalence: Device…
Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
*K900438MC2P Acetabular Component
Summary page 7
…ce Previous Premarket Notifications Omnifit 20° Series I Insert ® K900438 K243784 Omnifit® Crossfire® 10° Series II Insert K974685…
Osteonics Corp.19901
*K974685Osteonics Polyethylene Acetabular Components
Summary page 7
…K900438 K243784 Omnifit® Crossfire® 10° Series II Insert K974685 K243784 K890197 Constrained…
Osteonics Corp.19981
*K890197Omnifit Constrained Acetabular Bearing Insert
Summary page 7
…Omnifit® Crossfire® 10° Series II Insert K974685 K243784 K890197 Constrained Acetabular Insert K890197 Trident® Crossfire® 0° Polyethylene Insert K983382…
Osteonics Corp.1989—
*K983382Osteonics HA Generation II Acetabular Component System
Summary page 7
…K890197 Constrained Acetabular Insert K890197 Trident® Crossfire® 0° Polyethylene Insert K983382 K983502 K991952…
Osteonics Corp.19984
*K983502Osteonics Secur-Fit AD Generation II Acetabular Component System
Summary page 7
…Constrained Acetabular Insert K890197 Trident® Crossfire® 0° Polyethylene Insert K983382 K983502 K991952 K021911…
Osteonics Corp.19981
*K991952Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts
Summary page 7
…Trident® Crossfire® 0° Polyethylene Insert K983382 K983502 K991952 K021911 K233498…
Howmedica Osteonics Corp.1999—
*K021911Trident Crossfire Polyuethylene Liners
Summary page 7
…K983502 K991952 K021911 K233498 K243784 Trident® Cr…
Howmedica Osteonics Corp.2002—
*K233498Stryker Orthopaedics Hip Systems Labeling Update
Summary page 7
…K991952 K021911 K233498 K243784 Trident® Crossfire® 10° Polyethylene Insert K983382…
Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023—
*K993352Crossfire System 12 Acetabular Inserts
Summary page 8
…Previous Premarket Notifications System 12 Crossfire 10° Insert ® K993352 K121308 K243784 Trident® 0° C…
Howmedica Osteonics Corp.1999—
*K121308Hip Systems
Summary page 8
…cations System 12 Crossfire 10° Insert ® K993352 K121308 K243784 Trident® 0° Constrained Acetabular Insert K061654 Trident® Cons…
Howmedica Osteonics Corp.20127
*K061654Trident Constrained Acetabular Insert
Summary page 8
…352 K121308 K243784 Trident® 0° Constrained Acetabular Insert K061654 Trident® Constrained Acetabular Liner K233498 Trident® All Poly Constrained Acetabular Insert K243784 Omnifit® Cros…
Howmedica Osteonics Corp.2006—
*K951860Howmedice Bone Plug
Summary page 8
…784 Omnifit® Crossfire® 10° Eccentric Insert K974685 K243784 Artisan® Bone Plug K951860 K220838 K233498…
Howmedica Corp.1995—
*K220838Artisan Bone Plug, Universal Cement Restrictor
Summary page 8
…685 K243784 Artisan® Bone Plug K951860 K220838 K233498 K243784 UHR® Universa…
Howmedica Osteonics, Dba Stryker Orthopaedics2022—
*K800207Uhr UNIVERSAL6HIP Replacement
Summary page 8
…838 K233498 K243784 UHR® Universal Head Bipolar Component K800207 K910988 K993601…
Osteonics Corp.198036
*K910988Osteonics Ion Implanted Femoral Bearing Series
Summary page 8
…498 K243784 UHR® Universal Head Bipolar Component K800207 K910988 K993601 K173499…
Osteonics Corp.1991—
*K993601Howmedica Osteonics Femoral Heads
Summary page 8
…784 UHR® Universal Head Bipolar Component K800207 K910988 K993601 K173499 K222632…
Howmedica Osteonics Corp.19993
*K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
Summary page 8
…207 K910988 K993601 K173499 K222632 K233498…
Stryker Orthopaedics20182
*K222632UHR Bipolar Implants, Restoration GAP II Implants
Summary page 8
…988 K993601 K173499 K222632 K233498 K243784 Rationale f…
Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022—

Also cleared against K243784: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 30, 2026Class IIZ-3201-2026Process change controlAffected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading…
Jul 30, 2026Class IIZ-3199-2026Process change controlAffected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 32 years and passes through 10 companies; a new generation was cleared every 1.4 years on median.
  • 87 of the 327 ancestors have a recall of any class.
  • 1 other device also cites its predicate K243784.

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. 2026, 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?

Omnifit® 20 ° Series I Insert, Omnifit® Crossfire® 10 ° Series II Insert, Omnifit® Crossfire® 10 ° Eccentric Insert, Trident® Crossfire 0 ° and 10 ° Polyethylene Insert • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management…

Read the full statement (340 words)

Omnifit® 20 ° Series I Insert, Omnifit® Crossfire® 10 ° Series II Insert, Omnifit® Crossfire® 10 ° Eccentric Insert, Trident® Crossfire 0 ° and 10 ° Polyethylene Insert

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Constrained Acetabular Insert, Trident® 0 ° Constrained Acetabular Insert, Trident® Constrained Acet. Liner, Trident® All Poly Constrained Acetabular Insert

A Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

System 12 Crossfire® 10 ° Insert

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

• Rheumatoid arthritis;

• Correction of functional deformity;

• Revision procedures where other treatments or devices have failed; and,

• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

Artisan® Bone Plug

These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cement in a cemented hip procedure.

The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.

UHR® Universal Head Bipolar Component

• Femoral head/neck fractures or non-unions.

• Aseptic necrosis of the femoral head.

• Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

• Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.

• Salvaae of failed total hio arthroolastv.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K261624: Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261624

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026