DePuy Synthes Launches FIBULINK® Syndesmosis Repair System Designed to Enable Precise Tension Control and Physiologic Motion for Patients with Traumatic Ankle Injuries

FIBULINK System is Designed to Improve Tension Control, Eliminate Soft Tissue Disruption and Enable Physiologic Motion

WEST CHESTER, PA – October 22, 2020 – The Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes has launched the FIBULINK^® Syndesmosis Repair System in the United States for the treatment of traumatic injuries to the syndesmosis. The FIBULINK^® System is designed to enable precise, anatomic syndesmotic fixation to help restore the physiologic motion of the ankle following a traumatic injury.^1,2,3 DePuy Synthes acquired the technology earlier this year from Akros Medical, Inc.

A syndesmotic injury typically occurs from the external rotation of the talus (ankle bone) against the fibula, which results in pain and swelling and often requires surgical repair. These injuries occur in approximately 13-50% of all ankle fractures and 1-18% of all ankle sprains.⁴ Syndesmotic injuries historically have been repaired with cortex screws, but screw breakage has been reported in up to 36% of cases, which may lead to an expensive revision surgery.⁵ Another available treatment option, suture button constructs, have specific limitations including lack of two-way tension control and may necessitate medial soft tissue disruption during application and fixation.**^1,2

The FIBULINK^® Syndesmosis Repair System provides significant advancements over existing treatment options. It is the first system to offer a short high-strength suture bridge, which eliminates the risk of complications associated with broken syndesmotic screws.⁵ It is the only flexible syndesmotic repair system on the market that offers the ability to fine tune and readjust tension intraoperatively, allowing a surgeon to tighten and reverse the tension on the suture as needed to optimize the final gap between the tibia and fibula.**^1,2 The FIBULINK Syndesmosis Repair System delivers biomechanical superiority over Arthrex Syndesmosis TightRope^® XP Implant system, with the FIBULINK^® System providing 3x the fixation strength and 71% less elongation in a model simulating poor bone quality. ***⁶

The FIBULINK^® Syndesmosis Repair System enables a surgeon to perform syndesmotic fixation without a medial incision or hardware. This helps eliminate medial side complications, such as damage to neurovascular structures or soft tissue entrapment that may occur with suture button constructs. It also helps improve procedural efficiency by delivering fixation through a single lateral incision.**^,2

“FIBULINK has become my go-to for syndesmotic fixation,” said Dr. Samuel B. Adams****, Foot and Ankle Orthopaedic Surgeon, Durham, North Carolina. “The system combines flexible fixation, the ability to dial in compression, and no need to penetrate the medial cortex into one easily insertable device.”

The FIBULINK^® Syndesmosis Repair System Implants are offered in stainless steel or titanium, and are provided in sterile, single use kits. It is compatible with all DePuy Synthes distal fibula plates and any plate hole that accepts a 4 mm non-locking cortex screw.⁷

“The acquisition of Akros and subsequent launch of this key technology demonstrate a clear focus on accelerating meaningful innovation and strengthening DePuy Synthes’ Extremities portfolio – providing diverse solutions that enable customers to provide greater benefit to their patients,” said I.V. Hall*****, Worldwide President, Trauma, Extremities, CMF and Animal Health, DePuy Synthes. “This launch allows us to bring a differentiated solution that combines the benefits of stability and flexibility in the treatment of these common injuries.”

The DePuy Synthes FIBULINK^® Syndesmosis Repair System is being showcased during the 2020 Orthopaedic Trauma Association Virtual Annual Meeting. For further details about the FIBULINK System, visit: https://www.jnjmedicaldevices.com/en-US/product/fibulink-syndesmosis-repair-system

About Johnson & Johnson Medical Devices Companies

At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.

About DePuy Synthes

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*Comprising the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment
**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.
****Dr. Adams is a paid consultant to DePuy Synthes
*****Employee of Medical Device Business Services, Inc.

The third-party trademarks used herein are the trademarks of their respective owners.

1. DePuy Synthes. FIBULINK Competitive Evaluation Memo. 5/21/20. Windchill Document #0000303949.
2. DePuy Synthes. Syndesmosis Physiologic Motion & Soft Tissue Rationale. 5/22/20. Windchill Document #0000303937.
3. DePuy Synthes. FIBULINK Indications Memo. 5/12/20. Windchill Document #0000295747
4. Desai, S. Syndesmostic Injuries Treated with an Aperture Fixation Device. Techniques in Foot & Ankle Surgery. 2020;19(2):96-103.
5. 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.
6. DePuy Synthes. Fatigue Loading and Static Failure (FIBULINK Implant vs. Tightrope XP) 8/24/20 Windchill Document #0000304763.
7. DePuy Synthes. FIBULINK® Plate Compatibility Memo #0000295062. 2020

©DePuy Synthes 2020. All rights reserved.
156058-201016 DSUS

Please refer to the instructions for use for a complete list of indications, contraindications, warnings and precautions.

CONTACT: Meghan Grimaldi
Mgrimal4@its.jnj.com