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The Arthrotek® Maxfire™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The Arthrotek® Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of 2-0 Maxbraid™ ultra-high molecular weight polyethylene/polypropylene suture (Teleflex Medical, K040472) covered with two nonresorbable polyester or polyethylene sleeves. The anchors are pre-loaded on to an insertion instrument. The inserter allows for single entry into the joint. Once in the joint, the inserter will pierce the meniscus at the desired location. A pusher within the handle of the inserter allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the free ends of suture are gently pulled by the surgeon, drawing the loops into a flat, donut-shaped ring. This anchor sits on the backside of the meniscus. The suture is covered with either a polyester or polyethylene sleeve in order to control the size of the knot thus ensuring that the anchor does not become too small and pull through the meniscal tissue. By tensioning the suture, a sliding knot allows the meniscal tear to be compressed.

Indications for the 2.8 and 3.5mm LactoScrew® Suture Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/tendon repair.

The 2.8 and 3.5mm LactoScrew® Suture Anchors, which are comprised of LactoSorb® resorbable copolymer (85% PLLA/15% PGA), are molded suture anchors used to reattach soft tissue to bone. All 2.8 and 3.5mm LactoScrew® Suture Anchors are pre-loaded with either one or two sutures.

Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction. Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

The Hitch™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded with #2 polyethylene surgical sutures. The design enables the user to insert the implantable anchor by pushing the tip into the bone either through a pre-drilled hole, or by screwing it in through a tapped pre-drilled hole.

Indications for the ALLthread™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot: Lateral Stabilization, medial stabilization, Achilles tendon repair/reconstruction, Halluxvalgus reconstruction, mid- and forefoot reconstruction. Elbow: Tennis elbow repair, Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction. Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair.

The ALLthread™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolice resorbable material, preloaded with #2 polyethylene surgical sutures. The design will enable the anchor to be inserted either without pre-drilling or through a pre-drilled hole.

Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.

The EZLoc™ Femoral Fixation Device is the same design as the predicate Femoral Hook (EZLoc™), deared in K041261, with additional sizes. The device includes a body, an arm, a passing pin and a pull suture. The implant will be available in three diameters: 5-6mm, 7-8mm and 9-10mm; and five lengths: 15mm, 20mm, 25mm, 30mm and 35mm. The sizes will account for the varying diameters and lengths of the replacement graft and femoral tunnel length. Currently the devices are packaged with a #2 polyethylene suture, but may also be used with any legally marketed, nonresorbable suture.

The tibial screws and washers are indicated for the following procedures: 1. Anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction 2. Medial collateral ligament repair 3. Lateral collateral ligament repair 4. Posterior oblique ligament repair 5. Iliotibial band tenodesis reconstruction 6. Patellar ligament and tendon repair This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

The Nonresorbable CentraLoo™ Tibial Screws and Washers are a series of the seconding the Same of Sation of Sation to hans Device Deseription: - Ins designed for soft tissue fixation to bone.

The Ti-Screw Anchor SP is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand Indications - Ulnar/radial collateral ligament reconstruction. Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow Indications - Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee Indications - Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

The Ti-Screw Anchor SP consists of a screw tip, a screw body, and an internal cross pin to attach the suture. The screw tip engages the bone while the screw body provides the means to drive the anchor in, and the pin is used to attach the suture to the anchor.

Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following: Shoulder: Batkart repair, SLAP lesion repair, acromio-clavioular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnat/radial collateral ligament reconstruction. Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow: Tennis elbow repair, ultar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquus (VMO) muscle advancement. In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0mm screws are indicated for the following uses: - 1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction. - 2. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis). - 3. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.

The 3 mm, 4 mm, 6 mm, 10 mm, 11 mm, and 12 mm as well as the 9 mm x 35 mm Resorbable Interference Screws are an addition to the 7 mm, 8 mm, and 9 mm interference screws already cleared in 510(K) K982497. They are made of the same LactoSorb® material as the predicate devices.

Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

The Femoral Hook device includes a body and an arm. The body incorporates an eyelet that provides a means to attach the soft tissue grafts. The arm is used to anchor the body to the cortical bone.