510(k) · Decided
DecidedTitanium Cement Restrictor Material Pldla
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Apr 27, 2001 after a 63-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
- Apr 27, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK010529 Titanium Cement Restrictor Material PldlaMedtronic Sofamor Danek USA, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK022218 Cadence Cement RestrictorSpinal Concepts, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK023647 Cadence Peek Cemeent RestrictorSpinal Concepts, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK031318 Traxis Cement RestrictorSpinal Concepts, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK051607 Novaspine Cement Restrictor NSCRNovaspine, LLC · 2005
- Descendant · 3 generations on · 0 of its ownK041583 Peek Cement Restrictor X-BoxInnovasis, Inc. · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K022218Cadence Cement RestrictorSpinal Concepts, Inc. · 2002 · cites it directly4descendants
- K023647Cadence Peek Cemeent RestrictorSpinal Concepts, Inc. · 2002 · 2 generations on2descendants
- K031318Traxis Cement RestrictorSpinal Concepts, Inc. · 2003 · 2 generations on1descendant
- K051607Novaspine Cement Restrictor NSCRNovaspine, LLC · 2005 · 2 generations on0descendants
- K041583Peek Cement Restrictor X-BoxInnovasis, Inc. · 2004 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010529 | Titanium Cement Restrictor Material Pldla | Medtronic Sofamor Danek USA, Inc. | 2001 | — |
| +1 | K022218 | Cadence Cement Restrictor | Spinal Concepts, Inc. | 2002 | — |
| +2 | K023647 | Cadence Peek Cemeent Restrictor | Spinal Concepts, Inc. | 2002 | — |
| +2 | K031318 | Traxis Cement Restrictor | Spinal Concepts, Inc. | 2003 | — |
| +2 | K051607 | Novaspine Cement Restrictor NSCR | Novaspine, LLC | 2005 | — |
| +3 | K041583 | Peek Cement Restrictor X-Box | Innovasis, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022218 (Spinal Concepts, Inc., 2002) has gone furthest, with 4 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/K010529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010529: Titanium Cement Restrictor Material Pldla.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010529
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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