# K012193: Amc Antimicrobial Pin/Wire Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 11, 2002 after 364 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: 2 generations back to K850247 (1985). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 1.
- K961433: Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws, Electro-Biology, Inc. (1996) Summary page 1.
- K900263: Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (1990) Summary page 1.
- K965178: Niagara Dual Lumen Catheter, Vas-Cath, Inc. (1997) Summary page 1.
- K863354: Bio-Guard AB Coated Catheter, Cook Urological, Inc. (1986) Summary page 1.
- K961392: Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II, Sil-Med Corp. (1997) Summary page 1.

## Most influential descendants
- K022688: Versabond AB Bone Cement (2004), 0 descendants of its own
- K022676: Orthoguard AB Antimicrobial Sleeve (2002), 0 descendants of its own

## Indications for use
The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AI3 Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pidwire.

Source page: https://510kreport.com/device/K012193
Methodology: https://510kreport.com/methodology