510(k) · Cleared
Recalled · Class II · 2026Osteonics Secur-Fit AD Generation II Acetabular Component System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Dec 16, 1998 after a 71-day review. The FDA summary names its predicate without a number. 72 later devices descend from it. It has been recalled once.
- Decided
- Dec 16, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 0
72 later devices descend from it, 5 citing it directly.
- This deviceK983502 Osteonics Secur-Fit AD Generation II Acetabular Component SystemOsteonics Corp. · 1998
- Descendant · cites it directly · 69 of its ownK001449 Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000
- Descendant · 2 generations on · 68 of its ownK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled
- Descendant · 3 generations on · 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 · 4 generations on · 22 of its ownK101072 Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium…Howmedica Osteonics Corp. · 2011
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000 · cites it directly69descendants
- K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · 2 generations on68descendants
- K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008 · 3 generations on61descendants
- K040412Trident T Acetabular ShellsStryker Orthopaedics · 2004 · cites it directly23descendants
- K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp. · 2011 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983502 | Osteonics Secur-Fit AD Generation II Acetabular Component System | Osteonics Corp. | 1998 | — |
| +1 | K001449 | Trident Acetabular Shells: PS | Howmedica Osteonics Corp. | 2000 | — |
| +2 | K013676 | Trident Hemispherical Acetabular Shells | Howmedica Osteonics Corp. | 2001 | 8 |
| +3 | K081171 | Tritanium Acetabular Shell System | Howmedica Osteonics Corp. | 2008 | — |
| +1 | K040412 | Trident T Acetabular Shells | Stryker Orthopaedics | 2004 | — |
| +4 | K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite | Howmedica Osteonics Corp. | 2011 | — |
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 |
| 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 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 24.3 · 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 |
|---|---|---|---|
| * | — | Osteonics® Secur-Fit™-AD Acetabular Components Named without a submission number | |
| * | — | Osteonics® Modular Acetabular Cup System Named without a submission number | |
| * | — | Osteonics® Omnifit® Series II Cup Inserts Named without a submission number |
What descends from it? (72)
See all 725 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K001449 | Trident Acetabular Shells: PS | 2000 | 69 |
| K040412 | Trident T Acetabular Shells | 2004 | 23 |
| K991952 | Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts | 1999 | 20 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained… | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2026 | Class II | Z-3204-2026 | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K001449 (Howmedica Osteonics Corp., 2000) has gone furthest, with 69 descendants of its own.
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.
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 Osteonics® Secur-Fit™-AD Generation II Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Secur-Fit™-AD 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…
Read the full statement (116 words)
The Osteonics® Secur-Fit™-AD Generation II Acetabular Components are single-use devices.
The shells are intended for cemented or cementless fixation within the prepared acetabulum.
The Osteonics® Secur-Fit™-AD 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/K983502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983502: Osteonics Secur-Fit AD 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/K983502
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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