510(k) · Cleared
ClearedAstel Non-Metal Backed Acetabular Cup for Cemented
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-Tek Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Mar 26, 1990 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Mar 26, 1990
- Review
- 11 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK901240 Astel Non-Metal Backed Acetabular Cup for CementedMed-Tek Corp. · 1990
- Descendant · cites it directly · 17 of its ownK030153 Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32Zimmer, Inc. · 2003
- Descendant · 2 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 3 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
- Descendant · 3 generations on · 4 of its ownK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
- Descendant · 3 generations on · 4 of its ownK140975 Mastersl Femoral StemLima Corporate S.P.A. · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K030153Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32Zimmer, Inc. · 2003 · cites it directly17descendants
- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 2 generations on13descendants
- K141327Minima S SystemLima Corporate S.P.A. · 2014 · 3 generations on5descendants
- K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016 · 3 generations on4descendants
- K140975Mastersl Femoral StemLima Corporate S.P.A. · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901240 | Astel Non-Metal Backed Acetabular Cup for Cemented | Med-Tek Corp. | 1990 | — |
| +1 | K030153 | Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32 | Zimmer, Inc. | 2003 | — |
| +2 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +3 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
| +3 | K152903 | REVIVAL (TM) Modular Revision Hip Stem | Corin USA | 2016 | — |
| +3 | K140975 | Mastersl Femoral Stem | Lima Corporate S.P.A. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (18)
See all 182 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, K030153 (Zimmer, Inc., 2003) has gone furthest, with 17 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/K901240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K901240: Astel Non-Metal Backed Acetabular Cup for Cemented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901240
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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