510(k) · Decided
DecidedMacropore IB Resorbable Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macropore Biosurgery, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Aug 27, 2001 as substantially equivalent to K010529 (Medtronic Sofamor Danek USA, Inc., 2001) and 2 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Aug 27, 2001
- Review
- 84 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974017 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974017 | Timesh System | Sofamor Danek USA,Inc. | 1998 | 1 |
| −1 | K994158 | Macrosorbos Protective Sheet | Macropore Biosurgery, Inc. | 2000 | — |
| 0 (this device) | K011715 | Macropore IB Resorbable Plug | Macropore Biosurgery, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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 |
|---|---|---|---|
| * | K010529 | Titanium Cement Restrictor Material PldlaSummary page 2…ronic Sofamor Danek Titanium Cement Restrictor, and the MacroPore OS Protective Sheet, Class II medical device that were cleared for marketing in the United States under K010529, KO003718 and K994158 respectively. Indications For Use The MacroPore /B Resorbable Plug and the predicate device sharc substa… | 2001 |
| * | K003718 | Titanium Cement Restrictor (TCR)Summary page 2…or Danek Titanium Cement Restrictor, and the MacroPore OS Protective Sheet, Class II medical device that were cleared for marketing in the United States under K010529, KO003718 and K994158 respectively. Indications For Use The MacroPore /B Resorbable Plug and the predicate device sharc substantiaily eq… | 2001 |
| * | K994158 | Macrosorbos Protective SheetSummary page 2…tanium Cement Restrictor, and the MacroPore OS Protective Sheet, Class II medical device that were cleared for marketing in the United States under K010529, KO003718 and K994158 respectively. Indications For Use The MacroPore /B Resorbable Plug and the predicate device sharc substantiaily equivalent ind… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K010529.
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?
MacroPore IR Resarbable Plng is indicated for use as a cement restrictor in the femur, tibia and humerus.
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/K011715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011715: Macropore IB Resorbable Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011715
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026