# K012676: Reprocessed Used, Disposable Blades, Burs, Bits and Taps

- Pathway: 510(k) (Traditional)
- Applicant: Adven Medical
- Decided: Feb 4, 2002 after 174 days
- Product code: HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- 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) Disposable blades, burs, bits and taps marketed by Stryker: named in the summary without a submission number
- (no number) Disposable blades, burs, bits and taps marketed by Microair: named in the summary without a submission number
- (no number) Disposable blades, burs, bits and taps marketed by Synthes: named in the summary without a submission number
- (no number) Disposable blades, burs, bits and taps marketed by Komet: named in the summary without a submission number

## Indications for use
Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery. AMI intends to repr all brands of used disposable surglcal saw blades, burs, bits and taps. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the Joriginal manufacturer for single use) will be reprocessed by AMI.

Source page: https://510kreport.com/device/K012676
Methodology: https://510kreport.com/methodology