510(k) · Cleared
ClearedZca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Apr 1, 2003 as substantially equivalent to K901240 (Med-Tek Corp., 1990) and 2 other predicates after a 75-day review. Its family tree reaches back 1 generation to 1990. 17 later devices descend from it.
- Decided
- Apr 1, 2003
- Review
- 75 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K901240 (1990). 3 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK901240 Astel Non-Metal Backed Acetabular Cup for CementedMed-Tek Corp. · 1990
- This deviceK030153 Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32Zimmer, Inc. · 2003
- Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 4 of its ownK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
- Descendant · 2 generations on · 4 of its ownK140975 Mastersl Femoral StemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 3 of its ownK191374 Revival Modular Hip StemCorin U.S.A. Limited · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants
- K141327Minima S SystemLima Corporate S.P.A. · 2014 · 2 generations on5descendants
- K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016 · 2 generations on4descendants
- K140975Mastersl Femoral StemLima Corporate S.P.A. · 2014 · 2 generations on4descendants
- K191374Revival Modular Hip StemCorin U.S.A. Limited · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901240 | Astel Non-Metal Backed Acetabular Cup for Cemented | Med-Tek Corp. | 1990 | — |
| 0 (this device) | K030153 | Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32 | Zimmer, Inc. | 2003 | — |
| +1 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
| +2 | K152903 | REVIVAL (TM) Modular Revision Hip Stem | Corin USA | 2016 | — |
| +2 | K140975 | Mastersl Femoral Stem | Lima Corporate S.P.A. | 2014 | — |
| +2 | K191374 | Revival Modular Hip Stem | Corin U.S.A. Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (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 |
|---|---|---|---|
| * | K901240 | Astel Non-Metal Backed Acetabular Cup for CementedSummary page 1…Ziininer, Tnc. Zimmer Non-Metal Backed Acetabular Cup for Cemented Fixation (formerly Astel), K901240. cleared March 26,1990 ULTIMA All-UHMWPE Cemented Aceta… | 1990 |
| * | K924115 | Ultima All Uhmwpe Cemented Acetabular CupsSummary page 1…ULTIMA All-UHMWPE Cemented Acetabular Cups, manufactured by Johnson & Johnson, K924115, cleared Novcmber 24,1992 TriZoN Acclabular System Elevated Rim Liners,… | 1992 |
| * | K934765 | Trilogy Acetabular SystemSummary page 1…, cleared Novcmber 24,1992 TriZoN Acclabular System Elevated Rim Liners, manufactured by Zimmer, K934765, clcared ApriI 29,1994 Device Description: The ZCA Snap-In Cup is a single u… | 1994 |
| * | — | Trapezoidal-28 Snap-On Acetabular Cup Named without a submission number | |
| * | — | Müller Snap-On Acetabular Cup Named without a submission number |
What descends from it? (17)
See all 173 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?
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 | — |
What is it indicated for?
The acetabular cup is intended for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030153 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030153: Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030153
Report an extraction error
Are you the manufacturer?
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