# K051256: Silverseal Orthotic Component with X-Static

- Pathway: 510(k) (Traditional)
- Applicant: Noble Fiber Technologies, Inc.
- Decided: Jul 21, 2005 after 66 days
- Product code: ISH (Component, External, Limb, Ankle/Foot)
- Device class: 1
- Regulation: 21 CFR 890.3420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K043526 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043526: Silverseal Tubular Wound Dressing with X-Static, Noble Fiber Technologies, Inc. (2005) Summary page 1.

## Indications for use
SILVERSEAL® Orthotic Components with X-Static® are used as components on various orthotic devices intended for medical purposes that can be worn as a cervical collar or brace. The component comprises a knitted stockinette which is made of 90% cotton or polyester, and 10% X-Static®, which is 1.5% silver oxide. The component provides the skin with an antimicrobial barrier.

Source page: https://510kreport.com/device/K051256
Methodology: https://510kreport.com/methodology