510(k) · Cleared
ClearedCermet Iii Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implants International, Ltd. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Jul 25, 2007 as substantially equivalent to K040412 (Stryker Orthopaedics, 2004) after a 47-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jul 25, 2007
- Review
- 47 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941141 (1994). 26 ancestors in all, the oldest K903362 (1990). No later device cites it as a predicate yet.
- 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 backK040412 Trident T Acetabular ShellsStryker Orthopaedics · 2004
- This deviceK071583 Cermet Iii Acetabular Cup SystemImplants International, Ltd. · 2007
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 | K040412 | Trident T Acetabular Shells | Stryker Orthopaedics | 2004 | — |
| 0 (this device) | K071583 | Cermet Iii Acetabular Cup System | Implants International, Ltd. | 2007 | — |
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 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K040412 | Trident T Acetabular ShellsSummary page 1…intended use. Equivalent devices include the: Trident® "T' Acetabular Shells marketed by Stryker Orthopaedics (K040412 - S/E May 25, 2004) Indications: The CER-METTM III Acetabular Cup System is intended for un… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 10 of the 26 ancestors have a recall of any class.
- 3 other devices also cite its predicate K040412.
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. 2007, this device’s year, is highlighted.
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 CER-METTM III Acetabular Cup System is intended for
uncemented use for all types of arthrosis, such as advanced
destruction of the hip joint due to degenerative, post-traumatic or
rheumatoid arthritis, fracture or avascular necrosis of the femoral
head, sequelae of previous operations, such as internal fixation,
joint reconstruction, arthrodesis, hemiarthroplasty or total hip
replacement. The same considerations apply to acetabular
revisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071583: Cermet Iii Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071583
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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