510(k) · Cleared
ClearedOsteolock (TM) Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Oct 22, 1990 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 228 later devices descend from it.
- Decided
- Oct 22, 1990
- Review
- 88 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
228 later devices descend from it, 4 citing it directly.
- This deviceK903362 Osteolock (TM) Acetabular CupHowmedica Corp. · 1990
- Descendant · cites it directly · 216 of its ownK971854 Osteolock Acetabular Shell SystemHowmedica Corp. · 1997
- Descendant · 2 generations on · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
- Descendant · 3 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 4 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 2 generations on · 69 of its ownK001449 Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000
Showing 5 of 228 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 228 · See all- K971854Osteolock Acetabular Shell SystemHowmedica Corp. · 1997 · cites it directly216descendants
- K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · 2 generations on150descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 3 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 4 generations on83descendants
- K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000 · 2 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903362 | Osteolock (TM) Acetabular Cup | Howmedica Corp. | 1990 | — |
| +1 | K971854 | Osteolock Acetabular Shell System | Howmedica Corp. | 1997 | — |
| +2 | K001448 | Trident Acetabular Shells: PS-HA | Howmedica Osteonics Corp. | 2000 | — |
| +3 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +4 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +2 | K001449 | Trident Acetabular Shells: PS | Howmedica Osteonics Corp. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 10 | 0 |
| 2012 | 8 | 0 |
| 2013 | 11 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 15 | 0 |
| 2018 | 13 | 0 |
| 2019 | 12 | 0 |
| 2020 | 8 | 0 |
| 2021 | 14 | 0 |
| 2022 | 16 | 0 |
| 2023 | 13 | 0 |
| 2024 | 19 | 0 |
| 2025 | 26 | 0 |
| 2026 | 16 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (228)
See all 2284 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K971854 (Howmedica Corp., 1997) has gone furthest, with 216 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K903362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903362: Osteolock (TM) Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903362
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026