# K102834: Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)

- Pathway: 510(k) (Special)
- Applicant: Kinamed, Incorporated
- Decided: Jan 12, 2011 after 105 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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 no predicate by number.

## Most influential descendants
- K170206: Arthrex FiberTape Cerclage (2017), 5 descendants of its own
- K232755: Arthrex FiberTape and TigerTape Cerclage Sutures (2023), 2 descendants of its own
- K260018: Arthrex FiberButton (2026), 0 descendants of its own
- K243344: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (2025), 0 descendants of its own
- K243742: Arthrex DynaNite Nitinol Staples (2025), 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/K102834
Methodology: https://510kreport.com/methodology