510(k) · Cleared
Recalled · Class II · 2019Osteonics Polyethylene Acetabular Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Sep 22, 1998 after a 280-day review. The FDA summary names its predicate without a number. 29 later devices descend from it. It has been recalled once.
- Decided
- Sep 22, 1998
- Review
- 280 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 0
29 later devices descend from it, 4 citing it directly.
- This deviceK974685 Osteonics Polyethylene Acetabular ComponentsOsteonics Corp. · 1998
- 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 · cites it directly · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · 3 generations on · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- Descendant · 2 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K993352Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp. · 1999 · cites it directly18descendants
- K111546U2 Hip SystemUnited Orthopedic Corp. · 2011 · 2 generations on13descendants
- K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · cites it directly7descendants
- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · 3 generations on7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974685 | Osteonics Polyethylene Acetabular Components | Osteonics Corp. | 1998 | — |
| +1 | K993352 | Crossfire System 12 Acetabular Inserts | Howmedica Osteonics Corp. | 1999 | — |
| +2 | K111546 | U2 Hip System | United Orthopedic Corp. | 2011 | 1 |
| +1 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +3 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| +2 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | — | Osteonics Polyethylene Acetabular Components fabricated from standard polyethylene Named without a submission number |
What descends from it? (29)
See all 294 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 |
|---|---|---|---|---|
| Nov 7, 2019 | Class II | Z-0811-2020 | Employee error | May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire |
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?
Osteonics® Crossfire™ Polyethylene Acetabular Components are single use components, intended for use in conjunction with an associated Osteonics® metal acetabular shell, femoral bearing, and femoral hip stem, as part of a cemented or cementless total hip arthroplasty. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows: Painful, disabling joint disease of the hip resulting from…
Read the full statement (124 words)
Osteonics® Crossfire™ Polyethylene Acetabular Components are single use components, intended for use in conjunction with an associated Osteonics® metal acetabular shell, femoral bearing, and femoral hip stem, as part of a cemented or cementless total hip arthroplasty. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows:
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
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/K974685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974685: Osteonics Polyethylene 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/K974685
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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