# K012346: Vanguard Reprocessed Arthroscopic Blades

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Oct 16, 2001 after 84 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Dyonics Arthroscopic Blades: named in the summary without a submission number
- (no number) Stryker Arthroscopic Blades: named in the summary without a submission number
- (no number) Linvatec Arthroscopic Blades: named in the summary without a submission number

## Most influential descendants
- K052695: Suretek Medical Reprocessed Arthroscopic Blades and Burs (2006), 0 descendants of its own

## Indications for use
An arthroscopic blade is indicated for resection of soft and osseous tissues in articular cavities. Use of the device within paranasal sinuses (Funtional Endoscopic Sinus Surgery [FESS]) is limited to appropriately small blades (3.5 mm).

Source page: https://510kreport.com/device/K012346
Methodology: https://510kreport.com/methodology