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.

FIBULINK® Syndesmosis Repair System

Features & Benefits

The FIBULINK® System provides the best of both worlds: the fixation of a screw with the flexibility of a suture.

FB 1

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

FB 2

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

Plate Compatibility

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.

Resources

Surgical Technique Animation- FIBULINK® Syndesmosis Repair System
Surgical Technique Animation- FIBULINK® Syndesmosis Repair System
04:20
Features & Benefits Animation- FIBULINK® Syndesmosis Repair System
Features & Benefits Animation- FIBULINK® Syndesmosis Repair System
01:41

Supporting Documentation

Resources

References

*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.

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.

144285-200928 DSUS