# K201497: EVOS Cabling System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
- Decided: Oct 28, 2020 after 145 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: 5 generations back to K844068 (1985). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031162: Smith & Nephew Orthopaedic Cabling System, Smith & Nephew, Inc. (2003) Summary page 4.
- K992616: SDB Cerclage System, Pioneer Surgical Technology (1999) Summary page 4.

## Indications for use
The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.

Source page: https://510kreport.com/device/K201497
Methodology: https://510kreport.com/methodology