# K012694: Reprocessed Used Disposable Arthroscopic Blades and Burs

- 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
Longest line of descent: 1 generation back to K953695 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953695: Dyonics Disposable Arthroscopic Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 1.

## Indications for use
Arthroscopic blades and burs are single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor. Arthroscopy blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control. AMI intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only disposable, non angled arthroscopy blades and burs manufactured by Dyonics and Stryker, that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.

Source page: https://510kreport.com/device/K012694
Methodology: https://510kreport.com/methodology