510(k) · Cleared
ClearedTritanium Acetabular Shell System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 22, 2008 as substantially equivalent to K013676 (Howmedica Osteonics Corp., 2001) and 2 other predicates after an 89-day review. Its family tree reaches back 5 generations to 1994. 61 later devices descend from it.
- Decided
- Jul 22, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K941141 (1994). 24 ancestors in all, the oldest K903362 (1990). 61 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
- 4 generations backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
- 3 generations backK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
- 2 generations backK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
- 1 generation backK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled
- This deviceK081171 Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008
- Descendant · cites it directly · 22 of its ownK101072 Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium…Howmedica Osteonics Corp. · 2011
- Descendant · cites it directly · 21 of its ownK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- Descendant · 2 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- Descendant · 3 generations on · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- Descendant · 4 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp. · 2011 · cites it directly22descendants
- K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics · 2015 · cites it directly21descendants
- K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · 2 generations on21descendants
- K131237Pipeline Total Hip SystemPipeline Orthopedics · 2013 · 3 generations on20descendants
- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941141 | Precision Ostelock SP Femoral Component | Howmedica Corp. | 1994 | — |
| −4 | K972228 | Meridian Titanium Femoral Stems | Howmedica, Inc. | 1997 | — |
| −3 | K993768 | Citation TMZF HA Stem | Howmedica Osteonics Corp. | 2000 | 12 |
| −2 | K001448 | Trident Acetabular Shells: PS-HA | Howmedica Osteonics Corp. | 2000 | — |
| −1 | K013676 | Trident Hemispherical Acetabular Shells | Howmedica Osteonics Corp. | 2001 | 8 |
| 0 (this device) | K081171 | Tritanium Acetabular Shell System | Howmedica Osteonics Corp. | 2008 | — |
| +1 | K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite | Howmedica Osteonics Corp. | 2011 | — |
| +1 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
| +2 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| +3 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| +4 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 3 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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? (3)
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 |
|---|---|---|---|
| * | K013676 | Trident Hemispherical Acetabular ShellsSummary page 2…systems in regards to intended use, design, materials, and operational principles. The following devices are examples of predicate systems: Trident® Acetabular Systems (K013676 and K010170) and Implex/Zimmer's Hedrocel® Revision Cup (K001759). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2001 |
| * | K010170 | Trident Porous Titanium Acetabular ComponentSummary page 2…regards to intended use, design, materials, and operational principles. The following devices are examples of predicate systems: Trident® Acetabular Systems (K013676 and K010170) and Implex/Zimmer's Hedrocel® Revision Cup (K001759). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2001 |
| * | K001759 | Hedrocel Revision Cup, Model 02-2YY-ZZZZSummary page 2…tional principles. The following devices are examples of predicate systems: Trident® Acetabular Systems (K013676 and K010170) and Implex/Zimmer's Hedrocel® Revision Cup (K001759). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2000 |
What descends from it? (61)
See all 616 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite | 2011 | 22 |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use… | 2015 | 21 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K130895 | Reunion Rsa Shoulder System | 2013 | 14 |
| K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws | 2016 | 11 |
| K142606 | Trident® Tritanium® PST® Acetabular Shells | 2015 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 9 of the 24 ancestors have a recall of any class.
- Of its descendants, K101072 (Howmedica Osteonics Corp., 2011) has gone furthest, with 22 descendants of its own.
- 4 other devices also cite its predicate K013676.
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. 2008, 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?
The indications for use of the total hip replacement prostheses include:
1. Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
2. Revision of previous failed femoral head replacement, shell arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Where bone saock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
This acetabular shell is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081171: Tritanium Acetabular Shell System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081171
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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