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Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as bone fixation cerclage the sutures are intended for: - · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty) - · Sternotomy indications including the "rewiring" of osteomized sternums - · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring - · Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft) - · Repair of long bone fractures due to trauma or reconstruction - · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament - · Spinal applications including sublaminar and intrafacet wiring of the spinal column

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only. The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.

The Mbrace Cable is designed as a cerclage system for long bones and to reattach the greater trochanter in case of fractures or osteotomies. The device is intended for long-term implantation inside the human body for single use only. The Mbrace Cable is not intended for use as a suture cable in soft tissue approximation and/or ligation.

The Mbrace cable is an implantable flexible braided cable made of UHMWPE and designed as a cerclage bone system. The Mbrace cable is provided individually packed, sterile and single-use.

The Smith & Nephew ACCORD Cable System is indicated for use in general orthopaedic repair procedures including general cerclage of the femur, trochanteric reattachment, fixation of fractures in conjunction with intramedullary prosthesis (i.e., femoral stem) and screw fixation techniques.

The ACCORD Cable System includes cables (with or without clamps), trochanteric grips, and plates. (K223762). The Smith & Nephew ACCORD Cable System consists of Cobalt Chrome cables (without clamps) to be used with the ACCORD Titanium trochanteric grips or ACCORD Titanium plates and also Stainless Steel and Cobalt Chrome cables with clamps to be used alone. These materials are identical to the material that has been previously cleared in K223762, K031162, and K993106. The implants within this system are single-use and are Gamma sterilized.

The VariTrax Sternal CircumFixation system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The VariTrax Sternal CircumFixation System consists of polyetheretherketone (PEEK) locking bands with a detachable stainless-steel needle and a PEEK buttress plate. They are single-use devices provided in a sterile kit. The VariTrax bands are placed in peristernal fashion through the intercostal space with the help of the detachable needle. Once inserted, the needle is removed and the VariTrax implants are attached and locked to the VariTrax buttress plate, then tightened and secured in place to provide stable fixation of the sternum.

Arthrex Radiopaque FiberTape cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as bone fixation cerclage the sutures are intended for: • Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty) • Sternotomy indications including the “rewiring” of osteomized sternums • Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring - Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft) • Repair of long bone fractures due to trauma or reconstruction

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures assembled on an ABS loader. The Radiopaque FiberTape Cerclage implant is hitched around the post of the ABS loader which allows the nitinol wire to pass through the knot. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and polyester materials.

The STRETTO™ Cable System is indicated for use in: general orthopedic trauma surgery (e.g., fractures of the olecranon, patella, femur - including periprosthetic, pelvis, acetabulum, humerus and ankle, and acromioclavicular dislocations); prophylactic banding during total joint procedures; and, temporary reduction techniques for ORIF (Open Reduction Internal Fixation) procedures. STRETTO™ Screw Anchors are indicated for fractures that may not be securely held by either a screw or a cerclage device alone, and where cerclage is used in combination with bone screws and/or plates to provide internal fixation of fractured bone. STRETTO™ Press-In Anchors are indicated for use with a cerclage cable and plate to augment long bone fracture fixation, particularly when the use of screws would be inhibited, as in the presence of intramedullary implants.

The STRETTO™ Cable System implants are comprised of cables, crimps and anchors. Anchors include a thru hole for the cables to pass through, and are available in multiple styles. Press-in anchors mate with ANTHEM fracture plates and screw anchors mate with the hex recess of ANTHEM screws. The cable is secured with the crimp and may be used with the anchors. STRETTO™ Implants are manufactured from titanium alloy, commercially pure titanium, cobalt chromium alloy, cobalt chromium molybdenum alloy, or stainless steel.

HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for: - · Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring. - · Repair of long bone fracture due to trauma or reconstruction.

The Riverpoint Medical HS Fiber® Cerclage sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.

The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilizes the sternum after a sternotomy. The STERN FIX is a clamping device consisting of two parts, male and female, which match telescopically with one another to form the sternal stabilization system. Both male and female parts have a curved arm that catches one of the two halves of the sternum laterally and approximates them until the sternum is securely fixed. Five sizes of the STERN FIX are available for use with different sternum thicknesses. The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum. The predicate device was originally made of PEEK-OPTIMA™. This 510(k) introduces a new variant of the product made of carbon-fiber reinforced (CFR) PEEK-OPTIMA™. This new variant also presents some minor geometry changes with respect to the predicate device, to adapt the product to the new material.

The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.

The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilizes the sternum after a sternotomy. The STERN FIX is a clamping device consisting of two parts, male and female, which match telescopically with one another to form the sternal stabilization system. Both male and female parts have a curved arm that catches one of the two halves of the sternum laterally and approximates them until the sternum is securely fixed. Five sizes of the STERN FIX are available for use with different sternum thicknesses. The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum.

The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.

The EVOS Cabling System is used in orthopedic trauma and reconstructive surgeries to reduce and stabilize fractures and osteotomies. The EVOS Cabling System may be used for supplementary fracture fixation when used with bone plates or screws. The EVOS Cabling System includes a sterile, stainless-steel cable implant (ASTM F1314) packaged together with a stainless-steel crimp (ASTM F138). Non-sterile, reusable instruments are also provided to facilitate proper implantation of the cable-crimp implant.