510(k) · Cleared
Recalled · Class II · 2024Trident® II Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Oct 2, 2017 as substantially equivalent to K161569 (Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, 2016) and 3 other predicates after a 110-day review. Its family tree reaches back 8 generations to 1994. 10 later devices descend from it. It has been recalled 12 times.
- Decided
- Oct 2, 2017
- Review
- 110 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 12
- Predicates
- 4
Its longest line of descent runs back 8 generations to K921308 (1994). 43 ancestors in all, the oldest K903362 (1990). 10 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 7 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 6 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 5 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 4 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
- 3 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- 2 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
- 1 generation backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- This deviceK171768 Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017
- Descendant · cites it directly · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- Descendant · cites it directly · 6 of its ownK191358 Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
- Descendant · cites it directly · 5 of its ownK222632 UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
- Descendant · 2 generations on · 5 of its ownK220376 Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
- Descendant · 2 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · cites it directly6descendants
- K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · cites it directly6descendants
- K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · cites it directly5descendants
- K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · 2 generations on5descendants
- K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −7 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −6 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −5 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −4 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| −3 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| −2 | K122853 | Novel Fit and Fill Stem | Howmedica Osteonics Corp. | 2013 | — |
| −1 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
| 0 (this device) | K171768 | Trident® II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017 | — |
| +1 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
| +1 | K191358 | Trident II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
| +1 | K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022 | — |
| +2 | K220376 | Acetabular Dome Hole Plug | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022 | — |
| +2 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsSummary page 4…I, MEH Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: x Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws (K161569) x Osteonics Secur-FitTM HA Generation II [aka Trident PSL] Acetabular Shells (K983382, K143085) x Dome and Screw H… | 2016 |
| * | K983382 | Osteonics HA Generation II Acetabular Component SystemSummary page 4…x Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws (K161569) x Osteonics Secur-FitTM HA Generation II [aka Trident PSL] Acetabular Shells (K983382, K143085) x Dome and Screw Hole Plugs (K920868) Legally Marketed Reference Devices Used to Support Substantial Equiva… | 1998 |
| * | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Summary page 4…ritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws (K161569) x Osteonics Secur-FitTM HA Generation II [aka Trident PSL] Acetabular Shells (K983382, K143085) x Dome and Screw Hole Plugs (K920868) Legally Marketed Reference Devices Used to Support Substantial Equivalence: x Acco… | 2015 |
| * | K920868 | Acetabular Dome and Screw Hole PlugsSummary page 4…w Profile Hex Screws (K161569) x Osteonics Secur-FitTM HA Generation II [aka Trident PSL] Acetabular Shells (K983382, K143085) x Dome and Screw Hole Plugs (K920868) Legally Marketed Reference Devices Used to Support Substantial Equivalence: x Accolade II (K103479, K120578) x Stryker… | 1992 |
| † | K103479 | Novel Tapered Hip Stem | 2011 |
| † | K120578 | Accolade II Hip Stem | 2012 |
| † | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 |
| † | K142462 | Restoration Anatomic Shell | 2014 |
| † | K151264 | Restoration Anatomic Shell | 2015 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2024 | Class II | Z-1626-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1629-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1625-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1628-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1622-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1632-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1621-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1623-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1631-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1627-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1624-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Class II | Z-1630-2024 | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 18 of the 43 ancestors have a recall of any class.
- Of its descendants, K220731 (Stryker, 2022) has gone furthest, with 6 descendants of its own.
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. 2017, 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?
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…
Read the full statement (152 words)
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 of the acetabulum.
When used with MDM Liners
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner
The Trident Constrained Acetabular Insert is indicated for use 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.
The Trident® II Acetabular Shells are indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171768: Trident® II Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171768
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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