510(k) · Cleared
ClearedTrident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
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 14, 2016 as substantially equivalent to K081171 (Howmedica Osteonics Corp., 2008) and 1 other predicate after a 129-day review. Its family tree reaches back 6 generations to 1994. 11 later devices descend from it.
- Decided
- Oct 14, 2016
- Review
- 129 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K941141 (1994). 26 ancestors in all, the oldest K903362 (1990). 11 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
- 5 generations backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
- 4 generations backK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
- 3 generations backK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
- 2 generations backK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled
- 1 generation backK081171 Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008
- This deviceK161569 Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2016
- Descendant · cites it directly · 10 of its ownK171768 Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · Recalled
- Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- Descendant · 2 generations on · 6 of its ownK191358 Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
- Descendant · 2 generations on · 5 of its ownK222632 UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
- Descendant · 3 generations on · 5 of its ownK220376 Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · cites it directly10descendants
- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
- K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on6descendants
- K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · 2 generations on5descendants
- K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941141 | Precision Ostelock SP Femoral Component | Howmedica Corp. | 1994 | — |
| −5 | K972228 | Meridian Titanium Femoral Stems | Howmedica, Inc. | 1997 | — |
| −4 | K993768 | Citation TMZF HA Stem | Howmedica Osteonics Corp. | 2000 | 12 |
| −3 | K001448 | Trident Acetabular Shells: PS-HA | Howmedica Osteonics Corp. | 2000 | — |
| −2 | K013676 | Trident Hemispherical Acetabular Shells | Howmedica Osteonics Corp. | 2001 | 8 |
| −1 | K081171 | Tritanium Acetabular Shell System | Howmedica Osteonics Corp. | 2008 | — |
| 0 (this device) | K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2016 | — |
| +1 | K171768 | Trident® II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017 | 12 |
| +2 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
| +2 | K191358 | Trident II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
| +2 | K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022 | — |
| +3 | K220376 | Acetabular Dome Hole Plug | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081171 | Tritanium Acetabular Shell SystemSummary page 4…odes: LPH, KWZ, LZO, JDI, MEH Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: Tritanium® Acetabular Shell System (K081171) [Shell] Restoration Acetabular Cup (K943549) [Screw] Legally Marketed Reference Devices Used to Support Substantia… | 2008 |
| * | K943549 | Restoration Acetabular CupSummary page 4…arketed Predicate Devices to Which Substantial Equivalence is Claimed: Tritanium® Acetabular Shell System (K081171) [Shell] Restoration Acetabular Cup (K943549) [Screw] Legally Marketed Reference Devices Used to Support Substantial Equivalence: Tritanium® PL Cage (K152304)… | 1994 |
| † | K152304 | Tritanium PL Cage | 2015 |
| † | K142606 | Trident® Tritanium® PST® Acetabular Shells | 2015 |
| † | K944213 | 6.2 Vitallium Alloy Cancellous Bone Screw | 1994 |
| † | K903362 | Osteolock (TM) Acetabular Cup | 1990 |
| † | K983382 | Osteonics HA Generation II Acetabular Component System | 1998 |
| † | K151264 | Restoration Anatomic Shell | 2015 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171768 | Trident® II Acetabular System | 2017 | 10 |
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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 9 of the 26 ancestors have a recall of any class.
- Of its descendants, K171768 (Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, 2017) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K081171.
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. 2016, 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, 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 is inadequate…
Read the full statement (159 words)
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 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 Tritanium® Acetabular Shells are indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161569: Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161569
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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