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FIBULINK® Syndesmosis Repair System
FIBULINK® Syndesmosis Repair System
The FIBULINK® Syndesmosis Repair System provides the fixation of a screw and the flexibility of a suture, and is designed to enable precise, anatomic syndesmotic fixation.1,2 In addition, it addresses limitations of suture button constructs including lack of tension control and medial soft tissue disruption.*1,4
FIBULINK® implants are offered in stainless steel or titanium, and are provided as sterile, single use kits.
Key Resources
Surgical Technique Guide
Inventory Control Form
Instructions for Use
Features & Benefits
Improves Tension Control
- Rotation of the tensioning knob will advance or reverse tension until the desired correction is achieved.
- Precise tension adjustment capability is designed to optimize the final syndesmotic gap.*1,3
Eliminates Medial Disruption
- No medial incision, which helps improve procedural efficiency by delivering fixation through a single lateral incision.
- No medial hardware, which avoids complications such as damage to the superficial medial neurovascular bundle, tibialis anterior tendon entrapment and osteomyelitis associated with suture button constructs.*1
Enables Physiologic Motion
- Short, high strength PERMACORD® Suture bridge is designed to enable physiological syndesmosis motion.
- Provides superior biomechanical compared to the Arthrex Syndesmosis TightRope® XP Implant System, with a 206% increase in fixation strength and 71% less elongation in a poor quality bone model.**4
Plate Compatibility
Compatible with all DePuy Synthes distal fibula plates, specifically:
- All One-Third Tubular Plate holes (LCP® System and non-locking)
- Nonthreaded portion of a combi hole in a 3.5mm LCP® Plate
- Syndesmotic slots (VA LCP® Plates)5
Additionally, the 4mm FIBULINK® Implant is compatible with any distal fibula plate hole which accept a 4mm non-locking cortex screw. Various 3.5mm screw holes may accommodate the FIBULINK® Implant but compatibility must be verified.
Supporting Documentation
Resources
References
*Compared to suture button constructs.
** Bench testing may not be predictive of clinical performance. Sample size of n=8. Percentages and ratios based on averages. Attributes evaluated include fixation strength (load at 2mm), displacement and stiffness. P-value ≤ 0.001.
- DePuy Synthes. Syndesmosis Physiologic Motion & Soft Tissue Rationale. 5/22/20. Windchill Document #0000303937.
- DePuy Synthes. FIBULINK Indications Memo. 5/12/20. Windchill Document #0000295747.
- DePuy Synthes. FIBULINK Competitive Evaluation Memo. 5/21/20. Windchill Document #0000303949.
- DePuy Synthes. Fatigue Loading and Static Failure (FIBULINK Implant vs. Tightrope XP) 8/24/20 Windchill Document #0000304763.
- DePuy Synthes. FIBULINK Non-locking Plate Compatability Memo 6/30/2020 Windchill Document #0000295062.
The third party trademarks used herein are the trademarks of their respective owners.
Indication Statement
The FIBULINK® Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the FIBULINK Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Contraindications
Use of the FIBULINK® Syndesmosis Repair Kit is contraindicated in the presence of an acute local infection.
144139-201023 DSUS
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