510(k) · Cleared
Recalled · Class II · 2022Exactech All Poly Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Nov 14, 1996 after an 84-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Nov 14, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK963313 Exactech All Poly Acetabular CupExactech, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK121055 Mets Modular Total FemurStanmore Implants Worldwide, Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK133152 JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK140900 Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK140898 Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK121056 Mets Modular Proximal FemurStanmore Implants Worldwide, Ltd. · 2012
Most influential descendants
Showing 5 of 5 · See all- K121055Mets Modular Total FemurStanmore Implants Worldwide, Ltd. · 2012 · cites it directly3descendants
- K133152JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · 2 generations on2descendants
- K140900Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015 · 3 generations on0descendants
- K140898Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd. · 2015 · 3 generations on0descendants
- K121056Mets Modular Proximal FemurStanmore Implants Worldwide, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963313 | Exactech All Poly Acetabular Cup | Exactech, Inc. | 1996 | — |
| +1 | K121055 | Mets Modular Total Femur | Stanmore Implants Worldwide, Ltd. | 2012 | — |
| +2 | K133152 | JTS Extendible Distal Femoral Implant | Stanmore Implants Worldwide, Ltd. | 2014 | 1 |
| +3 | K140900 | Patient Specific Smiles Total Knee Replacement | Stanmore Worldwide Implants, Ltd. | 2015 | — |
| +3 | K140898 | Patient Specific Distal Femoral | Stanmore Implants Worldwide, Ltd. | 2015 | 2 |
| +1 | K121056 | Mets Modular Proximal Femur | Stanmore Implants Worldwide, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (6)
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 |
|---|---|---|---|
| * | — | T.A.R.A. by DePuy Named without a submission number | |
| * | — | Dual Lock by DePuy Named without a submission number | |
| * | — | New England Baptist System by DePuy Named without a submission number | |
| * | — | Triad System by Johnson and Johnson Named without a submission number | |
| * | — | Modular Hip System by Richard Named without a submission number | |
| * | — | Spectron Total Hip System by Richards Named without a submission number |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2022 | Class II | Z-1733-2022 | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121055 (Stanmore Implants Worldwide, Ltd., 2012) has gone furthest, with 3 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 | — |
What is it indicated for?
The Exactech All Polyethylene Acetabular Cup is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis and/or posttraumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.
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/K963313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963313: Exactech All Poly 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/K963313
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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