510(k) · Cleared
ClearedDuration Stabilized Uhmwpe
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 Jun 11, 1997 after a 274-day review. The FDA summary names no predicate by number. 19 later devices descend from it.
- Decided
- Jun 11, 1997
- Review
- 274 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK963612 Duration Stabilized UhmwpeHowmedica Corp. · 1997
- Descendant · cites it directly · 18 of its ownK993352 Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp. · 1999
- Descendant · 2 generations on · 13 of its ownK111546 U2 Hip SystemUnited Orthopedic Corp. · 2011 · Recalled
- Descendant · 3 generations on · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- Descendant · 4 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
- Descendant · 4 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K993352Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp. · 1999 · cites it directly18descendants
- K111546U2 Hip SystemUnited Orthopedic Corp. · 2011 · 2 generations on13descendants
- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · 3 generations on7descendants
- K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 4 generations on3descendants
- K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963612 | Duration Stabilized Uhmwpe | Howmedica Corp. | 1997 | — |
| +1 | K993352 | Crossfire System 12 Acetabular Inserts | Howmedica Osteonics Corp. | 1999 | — |
| +2 | K111546 | U2 Hip System | United Orthopedic Corp. | 2011 | 1 |
| +3 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| +4 | K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017 | — |
| +4 | K132455 | U-Motion II PS+ Cup | United Orthopedic Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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?
The FDA summary names no predicate by number.
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993352 | Crossfire System 12 Acetabular Inserts | 1999 | 18 |
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, K993352 (Howmedica Osteonics Corp., 1999) has gone furthest, with 18 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 P.C.A.® System Inserts (previously cleared in K921384) are intended to be used with P.C.A® Acetabular Shells, and Howmedica femoral stems and heads in cementless primary or cemented primary/revision total hip arthroplasty. The Premise® Hip Acetabular Components (previously cleared in K912426) are intended to be used with Howmedica femoral stems and heads in cemented primary or revision total hip arthroplasty. The Osteolock™ Inserts (previously…
Read the full statement (105 words)
The P.C.A.® System Inserts (previously cleared in K921384) are intended to be used with P.C.A® Acetabular Shells, and Howmedica femoral stems and heads in cementless primary or cemented primary/revision total hip arthroplasty.
The Premise® Hip Acetabular Components (previously cleared in K912426) are intended to be used with Howmedica femoral stems and heads in cemented primary or revision total hip arthroplasty.
The Osteolock™ Inserts (previously cleared in K903362), and the System 12® inserts (previously cleared in K851114 and K951115), when used with the Osteolock™ and Vitalock® Shells, are intended to be used with Howmedica femoral stems and heads in cemented primary or revision total hip arthroplasty.
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/K963612 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963612: Duration Stabilized Uhmwpe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963612
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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