# K022676: Orthoguard AB Antimicrobial Sleeve

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 23, 2002 after 42 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850247 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012193: Amc Antimicrobial Pin/Wire Sleeve, Smith & Nephew, Inc. (2002) Summary page 1.

## Indications for use
The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixatioii of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pine/wire.

Source page: https://510kreport.com/device/K022676
Methodology: https://510kreport.com/methodology