Super Staple™ and SuperSTEP™

Super Staple™

The Super Staple™ is a nitinol bone fixation implant that does more than anchor bone to bone. It offers high, constant, uniform compression and greater shape change than any implant in orthopaedic bone fixation surgery today¹.

Instant Compression

Delivered upon insertion, gives the surgeon inter-operative fixation confirmation and saves time.

Higher Compressive Force

Greater fixation force and pull-out resistance than body temperature and heat activated staples¹ to reduce the chances of fixation failure and risk of bone non-union.

Metric Design

Presents uniform compression throughout the osteotomy with the staple’s shape-changing bridge and legs, offering active reduction for bone-gap management.

Multiple Sizes and Forces

Hand, forefoot, mid-foot, rear-foot, and small bone fixation surgeries.

SuperSTEP™

The SuperSTEP™ nitinol staple, for the correction of flat feet or high arch deformities, provides high strength and force to ensure stable fixation at the fusion site. Upon delivery into bone, its unique and patented ZetaArc™ design secures the bone segments together and provides an ideal bone fixation and fusion environment.

Dimensions (mm)

Product	Bridge	Leg	Leg	Wire Diameter	Compression Force (lbf)*	Bridge Reduction**	Leg Reduction**
16601	09	07	07	1.5	7.4	13%	41%
21401	09	09	09	1.5	8.2	13%	32%
16801	11	10	10	1.5	10.9	13%	41%
16901	11	15	13	1.5	11.3	9%	41%
17001	13	10	10	1.5	9.6	9%	30%
17101	15	12	12	1.5	10.9	10%	40%
17201	15	12	12	2	13.5	13%	38%
17301	18	18	15	2	16.3	10%	38%
17401	20	20	20	2	18.6	8%	49%
17501	20	20	20	2X3	21.4	8%	49%
22001	25	25	25	2X3	26	6%	52%

SuperSTEP™

Product	Bridge	Leg	Leg	Wire Diameter	Compression Force (lbf)*	Bridge Reduction**	Leg Reduction**
20063	20	20	20	2×3	21.2	17%	42%
20083	20	20	22	2×3	21.2	17%	42%
20103	20	20	22	2×3	21.2	17%	42%

*Mean compression force (lbf, S.E. < 2.31)

Kit

The Super Staple™ comes in a convenient, sterile kit that includes the necessary instruments to prepare the surgical site and insert the implant into the bone.

Kit contains:

Staple pre-loaded in instrument,
Drill guide,
Tamp
Quick disconnect drill bit,
Pull pin, and
Two K-wires

Instrument

The Super Staple™ instrument both delivers the staple to bone using a push-in technique and can seat the staple as an impactor.

The SuperSTEP™ instrument is stepped to allow for ease of offset placement of the staple; a tamp is provided to further seat the staple into bone.

Common Procedures

The Super Staple™ and SuperSTEP™ are indicated for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

¹Super Staple Compression Data submitted to FDA.
**Mean bridge & leg reduction (%, S.E. <2.87)