# K153242: Frontier Medical Devices In-Line Orthopedic Cable Cerclage System

- Pathway: 510(k) (Traditional)
- Applicant: Frontier Medical Devices, Inc.
- Decided: Jan 13, 2016 after 65 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
Longest line of descent: 3 generations back to K844068 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151888: Frontier Medical Devices In-line Orthopedic Cable Cerclage System, Frontier Medical Devices, Inc. (2015) Summary page 4.
- K935481: Sponger Cable System, Modification, Pioneer Surgical Technology (1994) Summary page 4.
- K940729: Pioneer Laboratories Bone Plate with Cerclage Cables, Pioneer Surgical Technology (1994) Summary page 4.
- K941213: Songer Cable System, Pioneer Surgical Technology (1994) Summary page 4.
- (no number) Pioneer Laboratories’ Songer Cable System: named in the summary without a submission number

## Indications for use
The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.

Source page: https://510kreport.com/device/K153242
Methodology: https://510kreport.com/methodology