You are about to leave jnjmedicaldevices.com. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies.
FIBULINK® Syndesmosis Repair System
The FIBULINK® Syndesmosis Repair System is an implant solution providing the fixation of a screw and the flexibility of a suture. It is designed to enable precise, anatomic syndesmotic fixation.1,2 The FIBULINK System's flexible suture bridge eliminates the risk of complications and removal surgeries associated with broken syndesmotic screws.6 In addition, it addresses limitations of suture button constructs including lack of two-way tension control and medial soft tissue disruption.*1,3
FIBULINK® Implants are offered in stainless steel or titanium, and are provided as sterile, single use kits.
Features & Benefits
The FIBULINK® System provides the best of both worlds: the fixation of a screw with the flexibility of a suture.
Improves Tension Control
The only syndesmotic repair system that has the ability to fine tune and readjust tension intraoperatively.*1,3 The FIBULINK® System is designed to reduce the risk of over compression associated with suture button constructs.*1,3
Enables Physiologic Motion
Short, high strength suture bridge is designed to enable physiological syndesmosis motion.1,3 The FIBULINK® Implant provides higher pullout strength and less postoperative elongation than Arthrex TightRope®.**4,5
Eliminates Medial Disruption
Design eliminates medial soft tissue disruption and helps improve procedural efficiency by delivering fixation through a single lateral incision.*1 The FIBULINK® Implant eliminates medial side complications such as damage to the superficial medial neurovascular bundle, tibialis anterior tendon entrapment and osteomyelitis associated with suture button constructs.*1
The 4mm FIBULINK® Implant is compatible with any distal fibula plate hole which accept a 4mm non-locking cortex screw. Additionally, various 3.5mm screw holes may accommodate the FIBULINK® Implant but compatibility must be verified.
*Compared to suture button constructs.
** Bench testing may not be predictive of clinical performance.
1. DePuy Synthes. Syndesmosis Physiologic Motion & Soft Tissue Rationale. 2020.
2. DePuy Synthes. Fibulink Indications Memo, Windchill #0000295747. 2020.
3. DePuy Synthes. FIBULINK® Competitive Evaluation Memo. 2020.
4. DePuy Synthes. ETR-002 FIBULINK® Lateral Pull to Failure Test. Limited Sample Size performed by 3rd party accredited test lab.
5. DePuy Synthes. ETR-004 FIBULINK® Fatigue Test Report. Limited Sample Size performed by 3rd party accredited test lab.
6. Laflamme M, Belzile EL, Bedard L, van den Bekerom MP, Glazebrook M, Pelet S. A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture. J Orthop Trauma. 2015;29(5):216-223.
The third party trademarks used herein are the trademarks of their respective owners.
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.
Use of the FIBULINK® Syndesmosis Repair Kit is contraindicated in the presence of an acute local infection.
© DePuy Synthes 2020. All Rights Reserved. This site is published by the DePuy Synthes Companies, which are solely responsible for its content. This site is governed solely by applicable U.S. laws and governmental regulations. This site is for visitors from the United States. The third party trademarks used herein are the trademarks of their respective owners.