Control Cable System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K934557 ↗

FDA Product Code

JDQ

Device Class

Class II

Regulation

21 CFR Part 888.3010

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What types of materials are the cables in the Control Cable System made from, and how does this affect their use in orthopedic procedures?

  The Control Cable System cables are made from three different materials: stainless steel, titanium alloy, or cobalt chromium alloy. These materials are chosen for their strength, biocompatibility, and durability, which are critical for orthopedic trauma fixation and revision procedures. The choice of material may influence factors like corrosion resistance, weight, and magnetic properties, but all are designed to securely stabilize bone fragments or fractures when used with the included crimp mechanisms and DePuy Synthes plates and screws.

• Is the Control Cable System intended for reuse, or is it meant to be used only once? How should it be handled after use?

  The Control Cable System is explicitly designed for single-use in orthopedic settings. Since it is supplied in a sterilized case and includes disposable components like the passer handle, passer inserts, tensioners, and crimper, it should not be reused. After use, all components should be discarded according to medical device disposal protocols to maintain sterility and prevent cross-contamination.

• What instruments are included in the Control Cable System kit, and how do they contribute to the procedure?

  The kit includes a passer handle, passer inserts (large and small), cable tensioners, and a crimper, all housed in a sterilized case. The passer handle and inserts help guide the cables through bone tunnels or fracture sites, while the tensioners apply controlled force to secure the cables. The crimper then locks the cables in place, ensuring stable fixation alongside DePuy Synthes plates and screws for orthopedic trauma or revision procedures.

• How is the sterility of the Control Cable System maintained, and what storage instructions should be followed?

  The Control Cable System is supplied in a sterilized case, meaning it is pre-sterilized by the manufacturer for single-use. To preserve sterility, the case should remain unopened until immediately before use. After opening, the components should only be handled with sterile instruments or gloves. The system should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended for medical devices.

• What regulatory pathway does the Control Cable System follow, and how does this relate to its use in clinical settings?

  The Control Cable System holds an FDA 510(k) clearance under product code JDQ, classified under the Orthopedic Advisory Committee (OR). This means it was determined to be substantially equivalent to a legally marketed device and follows traditional FDA review. Clinically, this clearance indicates it meets U.S. safety and performance standards for orthopedic trauma fixation and revision procedures when used as intended with DePuy Synthes hardware.