# K261271: Cable-Ready® Cable Grip System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Jul 16, 2026 after 90 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: 11 generations back to K962616 (1996). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151907: Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables, Zimmer, Inc. (2015) Summary page 5.
- K992617: Hex Button, Pioneer Surgical Technology (1999)
- K151716: Cable-Ready Cable Grip System: Cable-Ready Bone Plate System, Zimmer, Inc. (2016) Summary page 5.
- K151848: Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System, Zimmer, Inc. (2016) Summary page 5.

## Cited in the summary but kept off the family tree
- K000734: Pioneer Surgical Technology Extended GTR, Model 501-601, Pioneer Surgical Technology (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Cerclage Cable with Crimp The Cerclage Cable with Crimp is indicated for use in skeletally mature patients to secure fractures of the olecranon, patella, femur, and humerus. The Cerclage Cable with Crimp can also be used in skeletally mature patients to reattach the greater trochanter after trochanteric osteotomy during total hip arthroplasty. Needle Cable The Needle Cable is indicated for use in skeletally mature patients for securing fractures of the olecranon, patella, and humerus. Cable Pin The Cable Pin is indicated for use in skeletally mature patients for olecranon fractures, patellar fractures, proximal humerus fractures, and greater tuberosity humerus fractures. Bone Plate with Cerclage Cable The Bone Plate with Cerclage Cable is indicated for use in skeletally mature patients where wire, cable, or band cerclage is used in combination with bone plates to provide fixation and/or stabilization of long bones. Examples include periprosthetic fractures or bone loss, comminuted shaft fractures, and nonunions of previous fractures with or without failed hardware. Greater Trochanter Reattachment (GTR) Device and GTR Cable The Greater Trochanter Reattachment (GTR) Device (including cables) is indicated for use in skeletally mature patients for the reattachment of the greater trochanter following osteotomy in total hip replacement and for fracture of the greater trochanter. The Extended GTR is additionally indicated for use in skeletally mature patients for reattachment of the greater trochanter in periprosthetic fractures of the femur. Hex Button The Hex Button is an optional accessory that, when used with a cerclage cable/wire, is indicated for use in skeletally mature patients for the following : • prevent cable migration and screw backout when interfaced with a screw • prevent cable migration when interfaced with a locking cap or plate

Source page: https://510kreport.com/device/K261271
Methodology: https://510kreport.com/methodology