510(k) · Cleared
Recalled · Class II · 2026Omnifit® 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 22 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 18 generations between
- 3 generations backK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- 2 generations backK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- 1 generation backK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- This deviceK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026
Show all 22 generations
- Root · 22 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 21 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 20 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 19 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 18 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 17 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 16 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 15 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 14 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 13 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 12 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 11 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 10 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 9 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 8 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 7 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 6 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 5 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- 4 generations backK211703 Insignia Hip StemStryker Orthopaedics · 2021
- 3 generations backK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- 2 generations backK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- 1 generation backK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −21 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −20 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −19 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −18 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −17 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −16 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −15 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −14 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −13 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −12 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −11 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −10 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −9 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −8 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −7 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| −6 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| −5 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| −4 | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
| −3 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
| −2 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| −1 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| 0 (this device) | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 6 | 0 |
| 1991 | 7 | 0 |
| 1992 | 7 | 0 |
| 1993 | 5 | 0 |
| 1994 | 27 | 0 |
| 1995 | 22 | 0 |
| 1996 | 20 | 0 |
| 1997 | 15 | 0 |
| 1998 | 16 | 0 |
| 1999 | 9 | 0 |
| 2000 | 24 | 0 |
| 2001 | 14 | 0 |
| 2002 | 22 | 0 |
| 2003 | 13 | 0 |
| 2004 | 10 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 10 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
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 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243784 | Stryker Orthopaedics Hip Devices Labeling UpdateSummary 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… | 2025 |
| * | K900438 | MC2P Acetabular ComponentSummary page 7…ce Previous Premarket Notifications Omnifit 20° Series I Insert ® K900438 K243784 Omnifit® Crossfire® 10° Series II Insert K974685… | 1990 |
| * | K974685 | Osteonics Polyethylene Acetabular ComponentsSummary page 7…K900438 K243784 Omnifit® Crossfire® 10° Series II Insert K974685 K243784 K890197 Constrained… | 1998 |
| * | K890197 | Omnifit Constrained Acetabular Bearing InsertSummary page 7…Omnifit® Crossfire® 10° Series II Insert K974685 K243784 K890197 Constrained Acetabular Insert K890197 Trident® Crossfire® 0° Polyethylene Insert K983382… | 1989 |
| * | K983382 | Osteonics HA Generation II Acetabular Component SystemSummary page 7…K890197 Constrained Acetabular Insert K890197 Trident® Crossfire® 0° Polyethylene Insert K983382 K983502 K991952… | 1998 |
| * | K983502 | Osteonics Secur-Fit AD Generation II Acetabular Component SystemSummary page 7…Constrained Acetabular Insert K890197 Trident® Crossfire® 0° Polyethylene Insert K983382 K983502 K991952 K021911… | 1998 |
| * | K991952 | Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene InsertsSummary page 7…Trident® Crossfire® 0° Polyethylene Insert K983382 K983502 K991952 K021911 K233498… | 1999 |
| * | K021911 | Trident Crossfire Polyuethylene LinersSummary page 7…K983502 K991952 K021911 K233498 K243784 Trident® Cr… | 2002 |
| * | K233498 | Stryker Orthopaedics Hip Systems Labeling UpdateSummary page 7…K991952 K021911 K233498 K243784 Trident® Crossfire® 10° Polyethylene Insert K983382… | 2023 |
| * | K993352 | Crossfire System 12 Acetabular InsertsSummary page 8…Previous Premarket Notifications System 12 Crossfire 10° Insert ® K993352 K121308 K243784 Trident® 0° C… | 1999 |
| * | K121308 | Hip SystemsSummary page 8…cations System 12 Crossfire 10° Insert ® K993352 K121308 K243784 Trident® 0° Constrained Acetabular Insert K061654 Trident® Cons… | 2012 |
| * | K061654 | Trident Constrained Acetabular InsertSummary 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… | 2006 |
| * | K951860 | Howmedice Bone PlugSummary page 8…784 Omnifit® Crossfire® 10° Eccentric Insert K974685 K243784 Artisan® Bone Plug K951860 K220838 K233498… | 1995 |
| * | K220838 | Artisan Bone Plug, Universal Cement RestrictorSummary page 8…685 K243784 Artisan® Bone Plug K951860 K220838 K233498 K243784 UHR® Universa… | 2022 |
| * | K800207 | Uhr UNIVERSAL6HIP ReplacementSummary page 8…838 K233498 K243784 UHR® Universal Head Bipolar Component K800207 K910988 K993601… | 1980 |
| * | K910988 | Osteonics Ion Implanted Femoral Bearing SeriesSummary page 8…498 K243784 UHR® Universal Head Bipolar Component K800207 K910988 K993601 K173499… | 1991 |
| * | K993601 | Howmedica Osteonics Femoral HeadsSummary page 8…784 UHR® Universal Head Bipolar Component K800207 K910988 K993601 K173499 K222632… | 1999 |
| * | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsSummary page 8…207 K910988 K993601 K173499 K222632 K233498… | 2018 |
| * | K222632 | UHR Bipolar Implants, Restoration GAP II ImplantsSummary page 8…988 K993601 K173499 K222632 K233498 K243784 Rationale f… | 2022 |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2026 | Class II | Z-3201-2026 | Process change control | Affected 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, 2026 | Class II | Z-3199-2026 | Process change control | Affected 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 devicesLPH 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
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.
https://510kreport.com/device/K261624 · printed Nov 6, 2026
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
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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