510(k) · Cleared
ClearedZCA All-Poly Acetabular Cups
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 Jul 16, 2020 as substantially equivalent to K901240 (Med-Tek Corp., 1990) and 1 other predicate after a 412-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Jul 16, 2020
- Review
- 412 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901240 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK901240 Astel Non-Metal Backed Acetabular Cup for CementedMed-Tek Corp. · 1990
- 1 generation backK030153 Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32Zimmer, Inc. · 2003
- This deviceK191449 ZCA All-Poly Acetabular CupsZimmer, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK252824 Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball…Signature Orthopaedics Pty, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K191449 | ZCA All-Poly Acetabular Cups | Zimmer, Inc. | 2020 | — |
| +1 | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026 | — |
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 |
|---|---|---|
| 2026 | 1 | 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? (2)
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 4…hip, semi-constrained, metal/polymer, cemented (21 CFR 888.3350) Predicate Device(s): K901240 NON-METAL MEDTEK BACKED (purchased by… | 1990 |
| * | K030153 | Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32Summary page 4…nc.) CUP FOR CEMENTED K030153 ZCA All-Poly Zimmer, Inc. Acetabular Cup,… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | 2026 | 0 |
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?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 17.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K252824 (Signature Orthopaedics Pty, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K901240.
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. 2020, this device’s year, is highlighted.
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 indicated 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191449: ZCA All-Poly Acetabular Cups.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191449
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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