510(k) · Cleared
Recalled · 2010Synthes in-Situ Bender/Cutter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Jul 24, 2002 after a 78-day review. The FDA summary names its predicate without a number. It has been recalled 5 times.
- Decided
- Jul 24, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 5
- Predicates
- 0
The FDA summary names its predicate without a number.
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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | MacroPore Macrosorb OS Protective Sheet Named without a submission number | |
| * | — | MacroPore DX screws and plates Named without a submission number | |
| * | — | Synthes Resorbable Fixation System Named without a submission number | |
| * | — | Synthes Resorbable Meshes and Sheets Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2010 | Not classified | Z-0825-2010 | Other | There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized. |
| Apr 3, 2009 | Not classified | Z-1641-2009 | Package design/selection | Sterility may be compromised due to a ineffective package design. |
| Apr 3, 2009 | Not classified | Z-1640-2009 | Package design/selection | Sterility may be compromised due to a ineffective package design. |
| Dec 18, 2008 | Not classified | Z-1248-2009 | Process control | The bender is heating prior to activation of the power button, requiring disassembly to stop heating. |
| Dec 18, 2008 | Not classified | Z-1249-2009 | Process control | The bender is heating prior to activation of the power button, requiring disassembly to stop heating. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Synthes (USA) In-Situ Bender/ Cutter is intended for use with Synthes resorbable fixation products in forming and/or cutting plates, meshes, sheets, screws, and tacks in-situ before, during, and after initial implantation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021458 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021458: Synthes in-Situ Bender/Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021458
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026