510(k) · Cleared
ClearedThe Universal Bone Cement Resistor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodynamic Technologies, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Feb 12, 1993 after a 169-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 12, 1993
- Review
- 169 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK924323 The Universal Bone Cement ResistorBiodynamic Technologies, Inc. · 1993
- Descendant · cites it directly · 5 of its ownK220838 Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics · 2022
- Descendant · 2 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 3 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · 2 generations on · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled
- Descendant · 3 generations on · 0 of its ownK250989 Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics · 2022 · cites it directly5descendants
- K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
- K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 3 generations on2descendants
- K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 2 generations on0descendants
- K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924323 | The Universal Bone Cement Resistor | Biodynamic Technologies, Inc. | 1993 | — |
| +1 | K220838 | Artisan Bone Plug, Universal Cement Restrictor | Howmedica Osteonics, Dba Stryker Orthopaedics | 2022 | — |
| +2 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +3 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +2 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | 2 |
| +3 | K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220838 | Artisan Bone Plug, Universal Cement Restrictor | 2022 | 5 |
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, K220838 (Howmedica Osteonics, Dba Stryker Orthopaedics, 2022) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K924323 · printed Nov 4, 2026
Cite this page
510(k) Report. “K924323: The Universal Bone Cement Resistor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924323
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026