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The Titan RC Tack is intended for soft tissue to bone fixation for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair KNEE Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair

The Titan RC Tack is a bioabsorbable implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three individual components: a tip, sleeve and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The Titan RC Tack is a sterile, single use device offered in one size, 4.5mm.

The 11mm & 12mm Absolute™ Absorbable Interference Screws are intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The Absolute™ Absorbable Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendonbone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in 11mm and 12mm diameters and 30mm in length.

The RC Multi-Suture Anchor is intended for soft tissue to bone fixation for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair KNEE Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair

The RC Multi-Suture Anchor is intended for fixation of soft tissue to bone in the shoulder, knee, and ankle. The device consists of a three-piece polymer implant assembled onto a delivery shaft. The implant is delivered manually using a delivery handle. The RC Multi-Suture Anchor is a sterile, single use device offered in one size, 4.5mm.

The proposed RC Tack is intended for soft tissue reattachment to host bone for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair KNEE Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair

The RC Tack is a polymmer implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three components: a tip, sleeve, and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The RC Tack is a sterile single use device offered in one size, 4.5mm.

The Bio-Interference Screw is intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The Bio-Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in varying diameters and lengths.

The Sutureless Anchor is intended for soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder.

The Sutureless Anchor is a biodegradable bone anchor intended for soft tissue to bone fixation in the repair of shoulder injuries. The device is offered in one size, 7.0mm. The Sutureless Anchor implant consists of three components: a sleeve, pin and washer. Upon deployment, the pin is driven through the center of the washer into the sleeve, expanding the sleeve radially to gain bone fixation. Simultaneously, a shearing mechanism releases the implant from the deployment shaft. The washer, fastened to the implant by the pin head, remains above the bone surface, tacking the soft tissue to the bone.

The intended use of the Intratunnel Tibial Fixation Fastener is for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

The Innovasive Intratunnel Tibial Fixation Fastener consists of two components, an Expansion Sheath, and Expansion Screw. Also included with the system is the instrumentation to place the devices and establish the tunnel. The device functions by establishing the tibia-femoral tunnel and placing the Expansion Sheath into the tibial tunnel. This is followed by screwing an Expansion Screw into the Sheath, expanding the Sheath which compresses the graft against the tunnel and creating fixation.

The Tibial Fastener is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.

Innovasive's proposed Tibial Fastener utilizes a central pin placed inside an outer sleeve. The central pin is threaded its entire length, resembling a "screw". The pin is cannulated in a hex shape to fit a Hex Driver for insertion into the outer sleeve. The pin is designed to lock into the central ID of the outer sleeve. The outer sleeve has a threaded central ID to accept the pin component, and an angled plate designed to lay flush against the tibia and prevent the device from pulling through the tibial tunnel. The angled plate will be offered in three angles: 40°, 45°, and 50° to accommodate varying tibial tunnel angles. The outer sleeve is manually placed in the tibial tunnel, and the graft passed through the sleeve's central ID. A Sizer is used to determine the appropriate pin diameter and length by insertion into the sleeve between the graft strands. The pin is than inserted into the central ID, and locks into the sleeve. Any excess graft ends may be removed. The proposed Tibial Fastener outer sleeve and central pin will be offered in various sizes to accommodate varying graft and tibial tunnel sizes.

The intended use of the Meniscal Dart is intended for use in the arthroscopic fixation of longitudinal, vertical meniscus lesions (bucket handle lesions) in the vascularized area of the meniscus (red-red and red-white areas).

The Meniscal Dart is a device fabricated from L-PLA which is intended for meniscal repair. The device consists of a molded device with a back tab and barbs along its length. The device is inserted into the meniscus with the aid of an inserter instrument. Additional instruments include calibration instruments to measure the depth of the tear. The Meniscal Dart is provided in 3 sizes, 10, 11 and 13mm.

The 3.5mm Metal ROC XS Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair KNEE Extra-capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repair Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair Mid-foot reconstructions FOOT Hallux valgus reconstruction ELBOW Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs BLADDER NECK SUSPENSION Bladder neck suspension for female urinary incontinence due to urethral hypermobility

The 3.5mm Metal ROC XS suture bone fastener implant tip portion consists of a shear pin, crown and anvil. The crown and anvil are fitted onto the shear pin component such that the crown component is located below the anvil on the shear pin. As the crown is pulled up during the device deployment, the anvil forces it open. The anvil is tapered such that it will fit into the crown component as the deployment action progresses. As the crown is forced open by the anvil, the crown expands to make contact with the surrounding bone. This expanding crown results in the final fixation properties of the device. Once the anvil is completely seated inside the crown, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole. In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole in the bone for the Fastener along with a deployment handle and hole finder. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose. The 3.5mm Metal ROC XS will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.