510(k) · Cleared
ClearedAtlas Iii Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Apr 3, 1997 as substantially equivalent to K912452 (Dow Corning Wright, 1991) and 2 other predicates after a 358-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Apr 3, 1997
- Review
- 358 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K911728 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK911728 Omnifit (R) Epf Dual Geomtry/Radius/Thread Acetab COsteonics Corp. · 1991
- This deviceK961388 Atlas Iii Acetabular CupFournitures Hospitalieres · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911728 | Omnifit (R) Epf Dual Geomtry/Radius/Thread Acetab C | Osteonics Corp. | 1991 | — |
| 0 (this device) | K961388 | Atlas Iii Acetabular Cup | Fournitures Hospitalieres | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 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 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? (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 |
|---|---|---|---|
| * | K912452 | HA Mccutchen SLT Hip SystemSummary page 1…ular Cup ~ Acetabular Cup Prosthesis, Hip, Acetabular Component, Ultra High Molecular Weight Polyethylene Hydroxylapatite McCutchen Acetabular Cup Dow Corning Wright (K912452) Omnifit-HA Acetabular Cup Osteonics Corp. (XK911728) Secure-Fit HA PSL Extra Acetabular Component System Osteonics Corp. (K9… | 1991 |
| * | K911728 | Omnifit (R) Epf Dual Geomtry/Radius/Thread Acetab CSummary page 1…r Component, Ultra High Molecular Weight Polyethylene Hydroxylapatite McCutchen Acetabular Cup Dow Corning Wright (K912452) Omnifit-HA Acetabular Cup Osteonics Corp. (XK911728) Secure-Fit HA PSL Extra Acetabular Component System Osteonics Corp. (K954023) The ATLAS® III Acetabular Cup is available in… | 1991 |
| * | K954023 | Osteonics Secur-Fit HA PSL Extra Acetabular Component SystemSummary page 1…Acetabular Cup Dow Corning Wright (K912452) Omnifit-HA Acetabular Cup Osteonics Corp. (XK911728) Secure-Fit HA PSL Extra Acetabular Component System Osteonics Corp. (K954023) The ATLAS® III Acetabular Cup is available in twelve (12) outer diameter (O.D.) sizes from 46 mm to 68 mm in two (2) mm increme… | 1995 |
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?
- None of the 3 ancestors has a recall.
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 ATLAS® III Acetabular Cup is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, and revision of previously failed hip arthroplasties. The device is designed for cementless application.
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/K961388 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961388: Atlas Iii Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961388
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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