510(k) · Cleared
ClearedDuration Stabilized Uhmwpe Acetabular Components
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 16, 1997 as substantially equivalent to K936132 (Howmedica, Inc., 1994) and 2 other predicates after an 80-day review. Its family tree reaches back 1 generation to 1986. 16 later devices descend from it.
- Decided
- Oct 16, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K855231 (1986). 3 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK855231 Howmedica Bipolar ProsthesisHowmedica Corp. · 1986
- This deviceK972792 Duration Stabilized Uhmwpe Acetabular ComponentsHowmedica Corp. · 1997
- Descendant · cites it directly · 15 of its ownK992153 PE-Plus Acetabular CupPlus Orthopedics · 1999
- 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 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K992153PE-Plus Acetabular CupPlus Orthopedics · 1999 · cites it directly15descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K855231 | Howmedica Bipolar Prosthesis | Howmedica Corp. | 1986 | — |
| 0 (this device) | K972792 | Duration Stabilized Uhmwpe Acetabular Components | Howmedica Corp. | 1997 | — |
| +1 | K992153 | PE-Plus Acetabular Cup | Plus Orthopedics | 1999 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K936132 | Exeter All Plastic Acetabular ComponentSummary page 1…cleared in submission K934060, as an alternate to standard air irradiated gamma sterilization. The additional components are the Exeter All Plastic Acetabular Component (K936132) and the Howmedica® Bipolar Prosthesis, Centrax® (K855231). Corresponding wear claims, previously cleared in submission K 963612… | 1994 |
| * | K855231 | Howmedica Bipolar ProsthesisSummary page 1…air irradiated gamma sterilization. The additional components are the Exeter All Plastic Acetabular Component (K936132) and the Howmedica® Bipolar Prosthesis, Centrax® (K855231). Corresponding wear claims, previously cleared in submission K 963612 and listed below, are also applicable to these additional… | 1986 |
| * | K934060 | Howmedica (R) Acetabular Comp Pack/Manuf Meth ChangeSummary page 1…d: 7-25-97 This submission describes additional UHMWPE acetabular components that can be sterilized by the Duration® Stabilized process previously cleared in submission K934060, as an alternate to standard air irradiated gamma sterilization. The additional components are the Exeter All Plastic Acetabular… | 1995 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992153 | PE-Plus Acetabular Cup | 1999 | 15 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K992153 (Plus Orthopedics, 1999) has gone furthest, with 15 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 Exeter All Plastic Acetabular Component (previously cleared in K936132) is
intended to be used for primary and secondary reconstruction of the bearing surface of
the acetabulum as a result of painful and/or severly disabled hip joints due to
osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or revision of a failed
acetabular component.
The Howmedica® Bipolar Prosthesis, Centrax® (previously cleared in K855231) is
intended to be used in conjunction with a femoral stem component for the
reconstruction of a femoral head damaged by fresh fracture, non-union, aseptic
necrosis of the head and neck, or by osteoarthritis or post-traumatic arthritis.
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/K972792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972792: Duration Stabilized Uhmwpe Acetabular Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972792
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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