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This device, Polymer OBL SB Series and Cinch Series Anchor/Suture Combination is intended for use only for the fixation of non-absorbable synthetic sutures for the following indications. The Polymer Cinch SB Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. Shoulder: - Bankhart Repair - SLAP Lesion Repair - Acromio-clavicular separation - Rotator Cuff Repair - Capsule and Capsulolabral Reconstruction - Biceps Tenodesis - Deltoid Repair Hand, Wrist, Elbow: - Scapholunate ligament reconstruction - Ulnar Collateral Ligament Reconstruction - Lateral Collateral Ligament Reconstruction - Biceps Tendon Reattachment - Elbow Medial/Lateral Repair of Tendons in the Elbow Foot: - Hallux Valgus Reconstruction - Mid and Forefoot Reconstruction Knee: - medial collateral ligament - lateral collateral ligament - posterior oblique ligament - Joint capsule closure - Illiotibial band tendonesis - VMO Advancement Urinary: Bladder Neck Suspension

The Polymer OBL SB Anchor is a simple modified polyacetal cylinder designed to be pushed through a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. Each anchor is preloaded with suture and includes an insertion device.. These components are packaged together sterile in double mylar/tyvek pouches or formed trays. The device is single use. The device can be used for open and arthroscopic procedures. The anchor is a modified cylinder made of polyacetal. From the end, the anchor is round with two grooves milled 180° apart. From the side, the anchor is a parallelogram with a hole through it. The anchors will be referred to by the diameter and the overall length, for example 2x8 means the diameter is 2.0 mm and the length is 8 mm. Refer to the drawing on page 12 for the dimensions "C" and "A". The largest anticipated size of the anchor is 3 mm in diameter and 15 mm in length (3x15). The smallest anticipated size of the anchor is 2 mm in diameter and 8 mm in length (2x8). The purpose of the hole through the device is to hold suture. The smooth longitudinal grooves on each side of the device allow the suture to pass into the bone hole without pinching the suture. The ends of the device are designed to initiate rotation of the device as it is pushed and subsequently pulled into place. The ends are tapered at angles that range from 30° to 60°. The anchor is symmetric, allowing it to be inserted with regard to which end enters first. The shape of the device distributes the load over a large bone surface reducing the risk of bone breakage or pullout. The Insertion Device is a manual surgical instrument comprised of a handle, sleeve, and piston. The handle is constructed from polypropylene and serves the functions of holding all pieces together and to interface between the surgeon's hand and the device. The sleeve houses the piston and the Anchor. The sleeve keeps the Anchor and piston in-line to allow the piston to push the Anchor into the implantation site. The Suture is Braided Polyester Suture from Surgical Specialties (See Appendix 3 for Approval Letters. N80950). The largest anticipated diameter of the suture USP #2. The smallest anticipated diameter of suture is USP #2-0. The suture is preloaded in the anchor eyelet. Materials Anchor: Polyacetal Inserter: Piston and Sleeve: Stainless Steel, Handle: Polypropylene Suture: Braided Polyester from Surgical Specialties, See Appendix 3. Use To implant the Anchor, the surgeon must first create an implantation site in bone. OBL supplies accessory drills and awls to prepare these sites. Once the implantation site is prepared, the surgeon simply aligns the Anchor to the hole, pushes the handle toward the bone, retracts, and disconnects the Suture from the Inserter. The Suture will be retained by the Anchor. Pulling back on the Suture further engages the Anchor into the walls of the hole. The surgeon is then left with an Anchor in the bone and Suture to attach to the soft tissue.

This device (Polymer Threaded Anchor and Cinch Polymer Threaded Anchor) is intended for use only for the fixation of non-absorbable synthetic sutures. The Polymer Threaded Series Anchor is intended for the fixation of surgical suture material for the following indications: Shoulder: - し、 Bankhart Repair - SLAP Lesion Repair vi - Acromio-clavicular separation 3. - Rotator Cuff Repair 4. - Capsule and Capsulolabral Reconstruction ર. - 6. Biceps Tenodesis - 7. Deltoid Repair Hand, Wrist, Elbow: - Scapholunate ligament reconstruction し、 - 2. Ulnar Collateral Ligament Reconstruction - 3. Lateral Collateral Ligament Reconstruction - 4. Biceps Tendon Reattachment - Elbow Medial/Lateral Repair of Tendons in the Elbow న్. Foot: - 1. Hallux Valgus Reconstruction - Mid and Forefoot Reconstruction 2. Knee: - medial collateral ligament l . - lateral collateral ligament 2. - posterior oblique ligament 3. - 4. Joint capsule closure - Illiotibial band tendonesis - VMO Advancement 6. The Cinch Polymer Threaded Anchor is intended only for the fixation of surgical material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The proposed device, Polymer Threaded Anchor, is a pre-packaged, sterile polyacetal implant. The device is used to secure soft tissue to bone. The device is to be used with reusable insertion devices including a drill, tap, drill/tap combination, and inserter. Surgeons may loop suture of his/her choice through the eyelet of the anchor for the attachment of soft tissue. The device is single use. The device can be used for open and arthroscopic procedures. The anchor is packaged sterile in double mylar/tyvek pouches or formed trays. The Polymer Threaded Anchor is a polyacetal screw designed to be screwed into a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. The anchor constists of a threaded portion to engage bone, an eyelet to retain suture, and a drive means to couple the device to the inserter. The anchor is referred to by it's major diameter of the largest thread). The sizes included in this submission are 2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm. Please see the drawings on page 9 for shape and dimensions of the device. The Insertion Device is a manual surgical instrument comprised of a handle and shaft. The handle is constructed from polypropylene and serves as the interface between the surgeon's hand and the device. The shaft serves the functions of transferring the torque from the surgeon's hand to the anchor. Materials Polyacetal Use To implant the Anchor, the surgeon must first create an implantation site in bone. OBL supplies accessory drills, taps and drill/tap combinations to prepare these sites. The inserter is used to screw the anchor into the implantation site. After the anchor is fully seated, the inserter is removed from the implantation site, leaving the anchor in the bone and suture through the anchor. The suture can then be used to attach soft tissue.

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures. The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications: Shoulder: - 1. Bankart lesion repairs - 2. SLAP lesion repairs - Acromio-clavicular separation repairs 3. - Rotator cuff tear repairs 4. - Capsular shift or capsulolabral reconstructions 5. - Biceps tenodesis 6. - Deltoid repairs 7. Foot and Ankle: - 1. Hallux Valgus repairs - Medial or lateral instability repairs/reconstructions 2. - Achilles tendon repairs/reconstructions 3. - Midfoot reconstructions 4. - Metatarsal ligament/tendon repairs/reconstructions 5. Elbow, Wrist, and Hand: - Scapholunate ligament reconstructions 1. - Ulnar or radial collateral ligament reconstructions 2. - Tennis elbow repair 3. - Biceps tendon reattachment 4. Knee: 1. - Extra-capsular repairs: - a. medial collateral ligament - lateral collateral ligament b. - c. posterior oblique ligament - Iliotibial band tenodesis 2. - Patellar realignment and tendon repairs, including vastus medialis 3. oblivious advancement The Cinch Threaded Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. The Cinch Threaded Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indication: Urinary: Bladder Neck Suspension

The proposed device, Polymer Threaded Anchor/Suture Combination, is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures. The device is used to secure soft tissue to bone. The device is pre-packaged so that the suture is looped through the anchor eyelet and the anchor/suture is installed in the inserter. The device is single use. The device can be used for open and arthroscopic procedures. These components are packaged together sterile in double mylar/tyvek pouches or formed trays. The Polymer Threaded Anchor is a polyacetal screw designed to be screwed into a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. The anchor consists of a threaded portion to engage bone, an eyelet to retain suture, and a drive means to couple the device to the inserter. The anchor is referred to by its major diameter of the largest thread). The sizes included in this submission are 2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm. The suture used in the proposed device is a braided polyester suture. The suture is multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture meeting USP requirements. The Insertion Device is a manual surgical instrument comprised of a handle and shaft. The handle is constructed from polypropylene and serves as the interface between the surgeon's hand and the device. The shaft serves the functions of transferring the torque from the surgeon's hand to the anchor. Materials: Anchor: Polyacetal Inserter: Piston and Sleeve: Stainless Steel, Handle: Polypropylene Suture: multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture from Surgical Specialties

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures. The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications: Shoulder: 1. Bankart lesion repairs 2. SLAP lesion repairs 3. Acromio-clavicular separation repairs 4. Rotator cuff tear repairs 5. Capsular shift or capsulolabral reconstructions 6. Biceps tenodesis 7. Deltoid repairs 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 or radial collateral ligament reconstructions 3. Tennis elbow repair 4. Biceps tendon reattachment Knee: 1. Extra-capsular repairs: a. medial collateral ligament b. lateral collateral ligament c. posterior oblique ligament 2. Iliotiband tenodesis 3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

The proposed device, Anchor/Suture Combination is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures. The device shall be used to secure soft tissue to bone. The device is pre-packaged so that the suture is looped through the anchor eyelet and the anchor/suture is installed in the inserter. The anchor implant site shall be prepared with an appropriate OBL drill. The inserter is used to screw the anchor into the implant site. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and suture looped through the anchor. The proposed device is constructed from the following materials. The anchor is made of titanium alloy TI6Al4VELI. The suture is multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture meeting USP requirements. The inserter shaft is a 300 series, 400 series, 17Cr-4Ni, or other alloy stainless steel.

The Cancellous Screw Washers designed for use in conjunction with cancellous bone screws. These implants are intended for fracture fixation of the metatarsals, and tarsal bones.

The proposed device, the Cancellous Screw Washer claims substantial equivalence to a currently marketed device, Synthes Screw Washer. The Synthes Screw Washer and the proposed device are available in either Titanium or Stainless Steel. Both function as added support under bone screw head and have no significant design differences.

function with a cannuiated bone screw used as internal fixation for the carpel, tarsal, metacarpal, and phalanges of the hand and foot.

The proposed device, the guidewires for cannulated screws claims substantial equivalence to a currently marketed device, Synthes guidewires. The Synthes guidew res and the proposed device are available in either stainless steel or Titanium alloy. Both function with a cannuiated bone screw used as internal fixation for the carpel, tarsal, metacarpal, and phalanges of the hand and foot. There are no significant design differences. The tips of the guidewires are pointed with either a trocar or diamond point for starting into the bone. The wires are normally used as temporary fixation of a fracture or osteotomy site until a bone screw can be driven over the wire and the wire removed

internal alignment and fixation for small bones of the hand and foot

Threaded Fixation Pin

Not Found

The proposed device, the small bone screw claims substantial equivalence to a currently marketed device, the Synthes mini-fragment bone screw. The Synthes screws and the proposed device are both available in Titanium and Stainless Steel. Both function as internal fixation for bones and have no significant design differences.