# K030256: Iso-Elastic Cerclage System

- Pathway: 510(k) (Traditional)
- Applicant: Kinamed, Inc.
- Decided: Oct 21, 2003 after 270 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K181749: SuperCable® Iso-Elastic™ Cerclage System (2018), 1 descendant of its own
- K063009: Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes) (2006), 1 descendant of its own
- K243344: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (2025), 0 descendants of its own
- K090686: Sic Brevetti S.R.L. Device for Sternal Synthesis (2009), 0 descendants of its own

## Indications for use
a. Repair of long bone fractures due to trauma or reconstruction; b. reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy; c. sternotomy closure; and d. sublaminar and intrafacet wiring of the spinal column.

Source page: https://510kreport.com/device/K030256
Methodology: https://510kreport.com/methodology