Search Results

The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture or size 3/0 TephaFLEX™ absorbable suture in repairs of the extremities such as those shown below: Foot and Ankle 1 Hallux Valgus repairs 2 Medial or lateral instability repairs/reconstructions 3 Achilles tendon repairs/reconstructions 4 Midfoot reconstructions 5 Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist and Hand 1 Scapholunate ligament reconstructions 2 Ulnar and radial collateral ligament reconstructions 3 Lateral epicondylitis repair 4 Biceps tendon reattachment

The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm diameter specifically for use in ankle, foot, elbow, wrist and hand repairs and reconstructions. The Axya Bone Anchor is available as a system together with a drill bit, a delivery/extraction handle and a drill guide. These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. The Axya Model 3000 Titanium Bone Anchor is prethreaded with either non-absorbable suture or size 3/0 TephaFLEX™ suture material.

The Axya Suture Welding System is indicated for use in securing sutures in soft tissues and for securing ligatures of tubular structures wherever conventional sutures or surgical staples are appropriate. The System may be used in arthroscopic, laparoscopic and open surgical procedures.

The Suture Welding System described in this Notice is a fully disposable singlepatient-use hand-piece with an internal (battery) power supply/controller. This device is designed for use in securing a specific suture (Axya Medical Tufflex™ Polyester suture) with a weld rather than with a traditional knot. This reduces the bulk of the suture fastening point and eliminates the possibility of knot slippage. The single-patient-use device eliminates the need for repair and maintenance of suture welding devices with reusable power supply/control units.

Tufflex™ Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Tufflex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Tufflex™ sutures are braided for optimal handling properties.

AxyaFlex™ polyester suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

AxyaFlex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. AxyaFlex™ sutures are braided for optimal handling properties.

The AxyaLoop™ Nonabsorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The device described in this submission is designed with a corkscrew style thread and is available in 3.0mm, 5.0mm and 6.5mm diameters, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor is available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Nonabsorbable Bone Anchor is prethreaded with USP polypropylene monofilament, USP nydon, USP braided polyester and USP braided polyethylene suture materials. The Nonabsorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

The Axya Model 6500 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 6.5 mm and 5 mm anchors may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.

The device is designed with a corkscrew style thread 6.5 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a bone punch and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 6500 Self-Tapping Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material. The Model 6500 Self-Tapping Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

The Axya Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The device is designed with a corkscrew style thread 3.0 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 3000 Bio-Absorbable Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material. The Model 3000 Bio-Absorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

The Axya Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing in The Axya Model 0500 AxyaLoop - Blo Fissone in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular Shoulder: Rotator curi, Bankart, and OEA: "Tocler." Total Capsulolabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Uinar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The device is designed with a corkscrew style thread 6.5 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 6500 Bio-Absorbable Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material. The Model 6500 Bio-Absorbable Bone Anchor is designed for use in both standard open t the Model of the state the limited in (arthreasenia) surgical procedures The Model 6500 Blo-Absorbable Dono Anoner 16 access and in mical procedures. surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

The Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The device described in this submission is designed with a corkscrew style thread and will be made available initially in a 5.0 mm nominal diameters, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axva Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 5000 Bio-Albsorbable Bone Anchor is prethreaded with USP polypropylene monofilament, USP nylon, JJSP braided polyester and USP braided polyethylene suture materials. The Model 5000 Bio-Absorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture in repairs of the extremities such as those shown below: Foot and Ankle 1 Hallux Valgus repairs 2 Medial or lateral instability repairs/reconstructions 3 Achilles tendon repairs/reconstructions 4 Midfoot reconstructions 5 Metatarsal ligament/tendon repairs/reconstructions Elbow wrist and Hand 1 Scapholunate ligament reconstructions 2 Ulnar and radial collateral ligament reconstructions 3 Lateral epicondylitis repair 4 Biceps tendon reattachment

The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm diameter specifically for use in ankle, foot, elbow, wrist and hand repairs and reconstructions. The Axya Bone Anchor is available as a system together with a drill bit, a delivery/extraction handle and a drill guide. These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 3000 Titanium Bone Anchor is prethreaded with size 2/0 USP non-absorbable monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers. The Model 3000 Titanium Bone Anchor is intended for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.