# K113028: Medisiss Reprocessed Arthroscopic Shavers and Burs

- Pathway: 510(k) (Traditional)
- Applicant: Medisiss
- Decided: Dec 20, 2011 after 70 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
Longest line of descent: 4 generations back to K862807 (1986). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940075: Shaver Blade Set, Arthrex, Inc. (1994) Summary page 1.
- K012536: Reprocessed Powered  Arthroscopic Accessories, Sterilmed, Inc. (2001) Summary page 1.
- K012667: Reprocessed Arthroscopic Shapers, Surgical Instruments Service and Savings, Inc. (2002) Summary page 1.

## Indications for use
MEDISISS Reprocessed Shavers and Burs are powered arthroscopic accessories intended for use in orthopedic joint surgery.

Source page: https://510kreport.com/device/K113028
Methodology: https://510kreport.com/methodology