510(k) · Cleared
Recalled · 2008Trident Hemispherical Acetabular Shells
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Dec 5, 2001 as substantially equivalent to K001448 (Howmedica Osteonics Corp., 2000) and 3 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1994. 68 later devices descend from it. It has been recalled 8 times.
- Decided
- Dec 5, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 8
- Predicates
- 4
Its longest line of descent runs back 4 generations to K941141 (1994). 21 ancestors in all, the oldest K903362 (1990). 68 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
- 3 generations backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
- 2 generations backK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
- 1 generation backK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
- This deviceK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001
- Descendant · cites it directly · 61 of its ownK081171 Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008
- Descendant · cites it directly · 23 of its ownK040412 Trident T Acetabular ShellsStryker Orthopaedics · 2004
- Descendant · 2 generations on · 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 · 3 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008 · cites it directly61descendants
- K040412Trident T Acetabular ShellsStryker Orthopaedics · 2004 · cites it directly23descendants
- K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp. · 2011 · 2 generations on22descendants
- 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 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941141 | Precision Ostelock SP Femoral Component | Howmedica Corp. | 1994 | — |
| −3 | K972228 | Meridian Titanium Femoral Stems | Howmedica, Inc. | 1997 | — |
| −2 | K993768 | Citation TMZF HA Stem | Howmedica Osteonics Corp. | 2000 | 12 |
| −1 | K001448 | Trident Acetabular Shells: PS-HA | Howmedica Osteonics Corp. | 2000 | — |
| 0 (this device) | K013676 | Trident Hemispherical Acetabular Shells | Howmedica Osteonics Corp. | 2001 | — |
| +1 | K081171 | Tritanium Acetabular Shell System | Howmedica Osteonics Corp. | 2008 | — |
| +1 | K040412 | Trident T Acetabular Shells | Stryker Orthopaedics | 2004 | — |
| +2 | 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 |
| +3 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 8 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 |
|---|---|---|---|
| * | K001448 | Trident Acetabular Shells: PS-HASummary page 1…entical to those of predicate devices. The predicate Trident® Hemispherical Shells with Plasma Spray and HA were found substantially equivalent via the 510(k) process in K001448 and K001449 respectively. Likewise, the Arc Deposited (AD) CP Titanium surface roughness coating was found substantially equivale… | 2000 |
| * | K001449 | Trident Acetabular Shells: PSSummary page 1…hose of predicate devices. The predicate Trident® Hemispherical Shells with Plasma Spray and HA were found substantially equivalent via the 510(k) process in K001448 and K001449 respectively. Likewise, the Arc Deposited (AD) CP Titanium surface roughness coating was found substantially equivalent in 510(k)… | 2000 |
| * | K943054 | Osteonics Secure-Fit AD Acetabular Component SystemSummary page 1…510(k) process in K001448 and K001449 respectively. Likewise, the Arc Deposited (AD) CP Titanium surface roughness coating was found substantially equivalent in 510(k) #K943054, and the AD-HA combination was found substantially equivalent via 510(k) #K942900. The substrate of the predicate hemispherical… | 1994 |
| * | K942900 | Osteonics Secure-Fit AD-HA Acetabular Component SystemSummary page 1…AD) CP Titanium surface roughness coating was found substantially equivalent in 510(k) #K943054, and the AD-HA combination was found substantially equivalent via 510(k) #K942900. The substrate of the predicate hemispherical shells is Titanium (Ti-6Al-4V ELI) Alloy conforming to ASTM F-620. The surface coa… | 1995 |
What descends from it? (68)
See all 685 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081171 | Tritanium Acetabular Shell System | 2008 | 61 |
| K040412 | Trident T Acetabular Shells | 2004 | 23 |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use… | 2015 | 21 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K142606 | Trident® Tritanium® PST® Acetabular Shells | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2008 | Not classified | Z-1174-2008 | Process design | Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals. |
| Jan 21, 2008 | Not classified | Z-1170-2008 | Process design | Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals. |
| Jan 21, 2008 | Not classified | Z-1168-2008 | Process design | Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals. |
| Jan 21, 2008 | Not classified | Z-1172-2008 | Process design | Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals. |
| Jan 21, 2008 | Not classified | Z-1173-2008 | Process design | Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals. |
| Jan 21, 2008 | Not classified | Z-1169-2008 | Process design | Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals. |
| Jan 21, 2008 | Not classified | Z-1171-2008 | Process design | Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals. |
| May 29, 2007 | Not classified | Z-1685-2009 | Labeling mix-ups | Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301 |
The 5 latest of 8 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 7 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 21 ancestors have a recall of any class.
- Of its descendants, K081171 (Howmedica Osteonics Corp., 2008) has gone furthest, with 61 descendants of its own.
- 3 other devices also cite its predicate K001448.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The subject Trident Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts. Indications: . 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…
Read the full statement (104 words)
The subject Trident Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts.
Indications:
. 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013676: Trident Hemispherical Acetabular Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013676
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026