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The ConMed Linvatec Intercept implants are for attaching soft tissue to bone in orthopedic surgical procedures to be used in either arthroscopic or open surgical procedures: The Intercept implants are intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.

The ConMed Linvatec Intercept Implant is a device that is used to assist the surgeon in re-attaching soft tissue to bone via interference fixation. The system includes implants, manufactured of PEEK (polyetheretherketone) material, in a range of sizes from 5mm to 8mm diameters and 12mm to 23mm lengths. A disposable driver is also part of the system.

The ConMed Linvatec Soft Tissue to Bone System is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The ConMed Linvatec Soft Tissue to Bone System includes anchors in a range of sizes and materials from 3.5 mm to 6.5 mm diameter and 15 mm to a 17 mm length with one (1) to three (3) non-absorbable suture configurations. The anchor sizes correspond to a series of general surgical instruments such as; bone taps, bone punches, drivers, and a suture passer.

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.

The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in sufure anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylene suture. The Bio Mini-Revo suture anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The Copolymer is inert and non-collagenous through the absorption process. The device will be available in two versions: with or without colorant D&C violet #2.

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The ConMed Linvatec Paladin Suture Anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with two nonabsorbable, braided, polyethylene sutures. The ConMed Linvatec Paladin Suture Anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The copolymer is inert and non-collagenous through the absorption process. The device will be available in 5.0mm - 6.5mm in size with colorant D&C violet #2.

The ConMed Linvatec Lightwave® Ablators are intended to be used for electrosurgical cutting and coagulation in arthroscopic procedures, using a conductive fluid environment. Additionally, the suction/aspiration versions of these devices have the capability for suctioning irrigation fluids. Electrosurgical cutting and coagulation may be performed in various joints such as the shoulder, ankle, wrist, elbow, knee, and hip.

The ConMed Linvatec LightWave® Ablators are comprised of a range of nonsuction and suction devices, operable by hand or foot control. The devices consist of an electrical, insulation-coated electrode and ceramic insulator attached to an integrated handle and cord set, allowing attachment to commonly available electrosurgical generators.

The MicroPower Hand Piece: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.

The MicroPower Hand Piece: Medium Speed Drill, Saggital saw. Reciprocating saw, and Oscillating saw device description is identical to the MicroChoice product line cleared in the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised. The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A cord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.

The MicroPower Hand Piece: High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.

The MicroPower Hand Piece High Speed Drill device description is identical to the MicroChoice product line cleared in the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised. The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A chord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.

The MicroPower Hand Piece: OralMax High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.

The MicroPower Hand Piece: Oral Max High Speed Drill device description MicroChoice product line cleared is identical to the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised. The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A chord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.

The Advantage® Turbo Drive System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurosurgical, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive and Spinal surgical procedures.

The Advantage® Turbo Drive System device description is identical to the original submission except for the modifications listed below. The modifications described in this Special 510(K) are listed below: 1. A new motor has been installed which provides additional torque and speed to the handpiece. 2. The software, Version 7.0, has been modified to allow Advantage@ Turbo Drive System to run at a maximum forward/reverse speed of 10.000 RMP or 12,000 RPM. This maximum speed is selectable using an appropriate code during the calibration request. All other software parameters used to run the Advantage@ Turbo Drive System operate in the same manner as all pre-existing software versions.

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet provide tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet are cannulated, sterile, single-use bone screws made of an absorbable homopolymer derived from Poly (L-Lactic Acid). Two sizes will be available for the device, 8 x 35mm and 8 x 40mm. The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, differ from the existing Linvatec BioScrew® XtraLok™ in that the major diameter is smaller. The violet colorant contained in this device, has been cleared for this product code and intended use by the FDA via color petition 8C0255 dated January 28, 1998. The modification does not affect the device's intended use, fundamental scientific technology or performance specifications.