Super Scaffold™ – Intramedullary Fixation Scaffold (IFS)

Intramedullary Fixation Scaffold System

The Super Scaffold™ is a tubular fenestrated intramedullary bone fixation implant and ingrowth scaffold for inter-digital fusion. It is fabricated from shape changing nitinol and is instantaneously active when implanted. The patent pending design of the Super Scaffold™ 1) locks into bone, 2) pulls bones together, 3) exerts high bone fixation forces, 4) maximizes the bone fusion interface area, and 5) allows bone ingrowth within the Super Scaffold™ and across the fusion. The Super Scaffold™ is the only intramedullary device that has the ability to shorten itself to pull bones together thus minimizing gap formation. It is also the only bone scaffold for inter-digital fusion.

High Force Bone Locking Bulges

Upon insertion and release the implant instantly shortens its length by expanding its bulges to lock into bone. Its diameter increases from 2.5mm to 7.5mm. Its bone locking force is 9.6N (2.2 lbf).¹

Distal and Proximal Bone Locking Wings

The distal and proximal ends of the Super Scaffold™ conform to the endosteal bone anatomy, and pairs of wings lock into its surface. The wings fixate the ends of the Super Scaffold™ into bone allowing the expanding bulge to pull bones together.
The wings’ unique design allows them to be threaded outward to enhance fixation or unthreaded to remove the implant from bone.

High Bone Compressive Force

As the implant expands, it shortens to apply compression forces to the healing interface and closes an inter-bony gap. The Super Scaffold™ shortens 3mm and applies up to 27.1N (6.0 lbf) force.

Bone Conducting Scaffold and High Fusion Interfacial Area

The fenestrated tubular Super Scaffold™ maximizes implant strength while minimizing its bone interface cross-sectional area. The fenestrated hollow design allows bone formation through the Super Scaffold™ and across the fusion site.

Conformal Anatomical Design

The 2.5mm Super Scaffold™ has been sized for lesser digit fixation. Its proximal and distal ends are slotted to allow the implant size to conform when pushed into the medullary canal. The shape changing bulge contours to the metaphyseal-diaphyseal intramedullary junction to lock into the endosteal surface and pull the Super Scaffold™ into bone.

Adjacent Joint K-Wire Fixation

The lumen of the Super Scaffold™ and implantation technique is unique in that a K-wire can be placed through the Super Scaffold™ to treat adjacent joints, such as the distal interphalangeal and metatarsal/metacarpal-phalangeal joint.

Removal

The 2.5mm Super Scaffold™ can be removed by unthreading it from bone. When turned counterclockwise and pulled gently the Super Scaffold™ bulge contracts to the implant centerline and the locking wings act as threads to unscrew the Super Scaffold™.

SuperScaffold™ Sizes

Product	Description
2265L3	IFS 2.2mm, 6.5mm Distal, Long, 3-Tabs
2565S3	IFS 2.5mm, 6.5mm Distal, Short, 3 Omega Bow

Kit

The 2.5mm Super Scaffold™ comes in a convenient, sterile kit that includes the necessary instruments to prepare the surgical site, implant the Super Scaffold™, and fixate adjacent joints.

Kit contains:

Super Scaffold™ implant pre-loaded in instrument,
Drill Bit,
K-wire (0.045″; 1.1mm)

Instrument

The Super Scaffold™ instrument holds the implant in its constrained and elongated form, delivers the implant into bone and releases the implant using an intuitive one-handed release mechanism.

Common Procedures

The Super Scaffold™ Fixation System is indicated for small bone fracture fixation, reconstruction and fusion such as inter-digital fusion of the fingers and toes (e.g. hammertoe correction and claw toe repair).

Hand Surgery: metacarpal to phalangeal and interphalangeal arthrodesis.
Foot Surgery: metatarsal to phalangeal and interphalangeal artrhodesis.

¹IFS Data submitted to FDA.