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The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.

The current Clavicle Fracture Fixation System accommodates fractures covering the mid-section and distal portions of the clavicle. As proposed in this 510(k) notification, the sponsor wishes to extend the product line by including a plate specifically designed for mid-shaft (i.e., non-distal) clavicle fractures. Because the proposed mid-shaft plate would not cover the distal aspect of the clavicle, its design will be slightly different. The proposed mid-shaft plate will be approximately 2/3 of the length of the current large size clavicle plate. Because the proposed mid-shaft plate will not engage the articular capsule of the clavicle, the distal screw holes of the current plate are eliminated. The proposed mid-shaft plate will be available in one size only with an overall length of approximately 100mm. The thickness of the plate will be the same as the Suspension™ clavicle plates now on the market. Likewise, the width of the mid-shaft plate will be the same as the mid-shaft portion of the current plates. The screws used to secure the proposed mid-shaft plate to the clavicle are the same as those used for the current Suspension™ clavicle plates. As with the current Suspension™ Clavicle Fracture Fixation plates, the proposed mid-shaft plate will be composed exclusively of 316L stainless steel. Implantable components are intended for re-sterilization, but are for single-use only. A hex driver with a handle and a hex driver shaft for hand-tightening bone screws is supplied with the device. These accessories are intended for re-use and re-sterilization. Drill bits are required for creating pilot holes for bone screws. These drill bits are included supplied with the clavicle plates and are steam sterilized by the hospital center.

The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures. For lateral clavicle fractures, the Suspension™ Clavicle Fracture Fixation System may also be used with the Suspension™ Acromioclavicular (AC) Repair System.

The subject device consists of the following implantable components: 1. Three sizes of clavicle fracture plate for each shoulder (i.e. small, medium, and large; each with Left & Right configurations) 2. Eight 2.7mm lengths of non-locking & locking bone screws 3. Eight 3.5mm lengths of non-locking & locking bone screws Implantable components are included in a carrier case and must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but are for singleuse only. All implantable components are composed of stainless steel. The optionally accompanying Suspension™ Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor with pre-threaded suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. Implantable portions of the device are: USP size 5 braided polyethylene suture, coracoid anchor, clavicle set screw, clavicle sleeve extension washer, clavicle sleeve.

The Suspension™ Acromioclavicular (AC) Repair System can be used for adult patients. The AC Repair System is indicated for securing suture to bone for acromioclavicular separations and coracoclavicular displacement.

The Suspension" Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor, pre-threaded suture and other attachment accessories that eliminate the need for tying a knot in the suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. The suture is a USP size 5, co-braided, white/blue polypropylene, non-absorbable suture.

The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.

The Suspension™ Clavicle Fracture Fixation System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from 316L Stainless Steel. The device consists of the following implantable components (some or all of which may be used based on the nature of the injury): - 1. Three (3) Sizes of Clavicle Fracture Plate for Each Shoulder (i.e. small, medium, and large; each with Left & Right). - 2. Eight (8) Lengths each of 2.7mm Non-Locking & Locking Bone Screws. - 3. Eight (8) Lengths each of 3.5mm Non-Locking & Locking Bone Screws. Implantable components are included in a surgical tray that must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but these components are for single use only. The implants are used with instrumentation including: - Hex Driver . - o Handle and a 2.5mm hex driver for hand tightening bone screws - Assorted Drill bits . - o To create pilot holes for bone screws. The drill bits are compatible with most AO connections. - Drill Guide Assemblies .