# K021458: Synthes in-Situ Bender/Cutter

- Pathway: 510(k) (Abbreviated)
- Applicant: Synthes (Usa)
- Decided: Jul 24, 2002 after 78 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MacroPore Macrosorb OS Protective Sheet: named in the summary without a submission number
- (no number) MacroPore DX screws and plates: named in the summary without a submission number
- (no number) Synthes Resorbable Fixation System: named in the summary without a submission number
- (no number) Synthes Resorbable Meshes and Sheets: named in the summary without a submission number

## Recalls of this device
- Jan 6, 2010 · Not classified · Z-0825-2010: 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: Sterility may be compromised due to a ineffective package design.
- Apr 3, 2009 · Not classified · Z-1640-2009: Sterility may be compromised due to a ineffective package design.
- Dec 18, 2008 · Not classified · Z-1248-2009: The bender is heating prior to activation of the power button, requiring disassembly to stop heating.
- Dec 18, 2008 · Not classified · Z-1249-2009: The bender is heating prior to activation of the power button, requiring disassembly to stop heating.

## Indications for use
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.

Source page: https://510kreport.com/device/K021458
Methodology: https://510kreport.com/methodology