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The Opus MiniMagnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The Opus MiniMagnum™ Anchor with Inserter is substantially equivalent to the existing Opus Magnum™ Anchor with Inserter and the Mitek Bioknotless Anchor cleared by the Food and Drug Administration. Additionally, the intended use of the Opus MiniMagnum™ Anchor with Inserter is identical and therefore substantially equivalent to the intended use of the existing Mitek BioKnotless Anchor, for fixation of soft tissue to bone. The purpose of this 510(K) is to notify the FDA of the clearance of a new Opus product, the Opus MiniMagnum™ Bone Anchor. The Opus MiniMagnum™ is substantially equivalent to Opus Magnum™ originally cleared under 510(k) 012125, but is smaller in size. The intended use and indications for use are the same as the predicate device, the Mitek BioKnotless Bone Anchor. The fundamental technology of the Opus MiniMagnum™ Bone Anchor System is substantially equivalent to the Opus Magnum™ Bone Anchor.

The Opus Magnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair.

Opus Magnum™ Anchor with Inserter

Is indicated for use for in placement of suture through soft tissue in endoscopic and other limited access procedures.

The Opus Medical SpeedStitch™ Suture Device is intended for use in endoscopic procodures as well as other limited access open procedures for the purpose of suturing soft tissues. The wen us oner minned docess open preedStitch™ is based on a hand held, manually powered suture punch for the dclivery of a suture needle through soft tissue. The device delivers a simple stitch using USP #2 braided suture.

The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.

The purpose of this 510(k) is to notify the FDA of a modification to the Opus Magnum® Implant System wherein a new suture, MagnumWire™, will be added as an option to provide convenience to the user. MagnumWire™ is substantially equivalent to FiberWire® USP braided polyester suture size #2 originally cleared under 510(k) 031083. The intended use and indications for use are the same as the predicate device. The addition of the use of MagnumWire™ with the Opus Magnum® Implant System does not alter the fundamental technology of the Opus Magnum® Implant System.

The Opus SmartStitch M-Connector is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures. The Opus SmartStitch Needle Cassette is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.

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The Opus SmartStitch M-Connector is indicated for use with a OM-8000 Actuation Handle for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures. The Opus SmartStitch Actuation Handle is indicated for use with a OM-8007 M-Connector for placement of USP size #2 braided polyester suture (not supplied) through soft tissue in endoscopic and other limited access procedures.

Reusable SmartStitch® Suture Device

The Opus Magnum Implant is intended for fixation of tendon to bone using a "silky" II Polydek® non-absorbable braided polyester or FiberWire® braided polyblend USP size #2 suture for the indications listed below. The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation. Bone stock must be adequate to allow proper placement. Indications: (1) Shoulder 1) Rotator Cuff Repair

The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation.

The Device is indicated for hair removal and permanent hair reduction in dermatology and plastic surgery procedures.

The F1 Diode Laser System delivers a pulsed infrared laser light at a wavelength of 810 nanometers. The laser consists of several interconnected sections: The cabinet which houses the laser diode, the power supply, the PC-104, and the microcontroller, the umbilical which houses the fiber optics delivery system, and the handpiece and the external TE chiller.

SmartStitch Suture Device: The Opus SmartStitch M-Connector (Model #OM-8005) is indicated for use with a Actuation Handle (Model #OM-8500) and Suture Cartridges (Models #OM-8051, -8052, -8053) for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures. SmartStitch Sutures: The Opus Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, orthopedic, and neurological procedures.

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The Opus SmartStitch Suture Device is indicated for use for placement of #2 Braided Polyester Suture (such as Genzyme Polydek®) through soft tissue in endoscopic and other limited access procedures.

SmartStitch® Suture Device