510(k) · Cleared
Recalled · Class II · 2014Osteonics HA Generation II Acetabular Component System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Dec 11, 1998 after a 77-day review. The FDA summary names its predicate without a number. 153 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 11, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 4
- Predicates
- 0
153 later devices descend from it, 10 citing it directly.
- This deviceK983382 Osteonics HA Generation II Acetabular Component SystemOsteonics Corp. · 1998
- Descendant · cites it directly · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
- Descendant · 2 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 3 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 3 generations on · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 68 of its ownK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled
Showing 5 of 153 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 153 · See all- K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · cites it directly150descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 2 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 3 generations on83descendants
- K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · 3 generations on68descendants
- K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · 2 generations on68descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983382 | Osteonics HA Generation II Acetabular Component System | Osteonics Corp. | 1998 | — |
| +1 | K001448 | Trident Acetabular Shells: PS-HA | Howmedica Osteonics Corp. | 2000 | — |
| +2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +3 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +3 | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +2 | K013676 | Trident Hemispherical Acetabular Shells | Howmedica Osteonics Corp. | 2001 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 9 | 0 |
| 2019 | 10 | 0 |
| 2020 | 7 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 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? (5)
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 |
|---|---|---|---|
| * | — | Osteonics® Secur-Fit™-HA Acetabular Components (previously known as the Osteonics®… Named without a submission number | |
| * | — | Osteonics® Modular Acetabular Cup System Named without a submission number | |
| * | — | Osteonics® Secur-Fit™ HA X’tra Acetabular Component System Named without a submission number | |
| * | — | Osteonics® Threaded HA Acetabular Shells Named without a submission number | |
| * | — | Osteonics® Omnifit® Series II Cup Inserts Named without a submission number |
What descends from it? (153)
See all 15310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K001448 | Trident Acetabular Shells: PS-HA | 2000 | 150 |
| K040412 | Trident T Acetabular Shells | 2004 | 23 |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use… | 2015 | 21 |
| K991952 | Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts | 1999 | 20 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K171768 | Trident® II Acetabular System | 2017 | 10 |
| K221149 | U-Motion II Acetabular System-Extension line | 2023 | 1 |
| K253948 | Momentum Acetabular Cup System | 2026 | 0 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained… | 2026 | 0 |
| 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 |
|---|---|---|---|---|
| Dec 15, 2014 | Class II | Z-1043-2015 | Process control | Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present. |
| Aug 30, 2007 | Not classified | Z-0073-2008 | Process control | Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one… |
| Aug 30, 2007 | Not classified | Z-0072-2008 | Process control | Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one… |
| Mar 13, 2006 | Not classified | Z-1261-2007 | Other | Dimensional anomaly |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K001448 (Howmedica Osteonics Corp., 2000) has gone furthest, with 150 descendants of its own.
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 Osteonics® HA Generation II Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® HA Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination. Indications: ° Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or…
Read the full statement (114 words)
The Osteonics® HA Generation II Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® HA Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.
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 failed 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/K983382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983382: Osteonics HA Generation II Acetabular Component System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983382
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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