# K012667: Reprocessed Arthroscopic Shapers

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instruments Service and Savings, Inc.
- Decided: Jun 3, 2002 after 294 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 2 (0 Class I)
- 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) Same single use shaper as provided by the original manufacturer: named in the summary without a submission number

## Most influential descendants
- K113028: Medisiss Reprocessed Arthroscopic Shavers and Burs (2011), 0 descendants of its own

## Recalls of this device
- May 3, 2013 · Class II · Z-1641-2013: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
- May 3, 2013 · Class II · Z-1633-2013: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

## Indications for use
The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.

Source page: https://510kreport.com/device/K012667
Methodology: https://510kreport.com/methodology