The FastForwardTM Bunion Correction System addresses hallux valgus (bunion) deformities by reducing the 1st intermetatarsal angle using a unique bone-sparing tethering approach. Traditional bunion surgical approaches have involved significantly cutting, realigning and/or fusing the 1st metatarsal. However, these procedures are associated with long recovery periods and complications including nonunion, avascular necrosis, and limb shortening. Tethering suture material between the 1st and 2nd metatarsals has been described as an alternative bone-sparing approach to reduce the deformity. However, peer-reviewed studies have reported the occurrence of second metatarsal fractures due to stress concentrations created by the suture-button implant and the requirement to drill through the second metatarsal.
The FastForwardTM Bunion Correction System solves many of the issues associated with other surgical procedures by offering the following features:
- Tethering of QuikCord Suture Tape between 1st and 2nd metatarsals to reduce the deformity without significantly cutting or fusing bone
- Titanium alloy (Ti-6Al-4V) Bone Tether Plate that shields 2nd metatarsal from stresses
- Cow Hitch Knot with suture tape eliminates drilling through 2nd metatarsal
- PEEK (polyetheretherketone) Interference Screws securely lock QuikCord in 1st metatarsal
The FastForwardTM Bone Tether Plate, represents a breakthrough in bunion correction by aiding in securely wrapping QuikCord around the 2nd metatarsal while preserving and protecting the structural and mechanical integrity of the bone. The plate is MedShape's first implant manufactured using innovative 3-D printed titanium technology. The 3-D printing process provides the FastForwardTM device with several unique design features:
- Elongated wing design to broadly distribute forces across bone
- Low-profile loop to securely hold QuikCord to minimize contact between Tape and bone
- Large, open pores to allow for bone growth around the implant
- Overall geometry that provides the 2nd metatarsal with 85% higher fracture strength compared with suture-button tethering devices1
The FastForwardTM Bunion Correction system also includes a set of PEEK Interference Screws designed to reliably fixate QuikCord in the 1st metatarsal. The Screws have a 4.75 mm diameter and are available in three different lengths to align with the 1st metatarsal anatomy.
The FastForwardTM Bone Tether Plate and PEEK Screw System have been cleared by the United States Food and Drug Administration for sale in the United States. Protected by U.S. Patent No. 8,821,551. Other U.S. and International Patents Pending.
Achieve complete anatomic correction while preserving and protecting bone.
1Smith KE, Gall K, et al. Use of 3D Printed Bone Plate in Novel Technique to Surgically Correct Hallux Valgus Deformities. Techniques in Orthopaedics, 2016 (Accepted, in press).