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Artisan Bone Plug: These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cement in a cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal. Universal Cement Restrictor: For cement spacers, mid-shaft restrictors and Cement Plugs: In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

The Artisan Bone Plug and Universal Cement Restrictor are commercially available devices that have been determined substantially equivalent in previous 510(k) premarket notifications. The purpose of this submission is to modify the labeling of these devices to add MR Conditional labeling and make other minor labeling updates.

The Tornier Cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during joint arthroplasty. The Tornier Cement restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation when the implant is introduced.

The Tornier Cement Restrictor is a diaphyseal plug for orthopedic use. It is designed to occlude the medullary cavity before the introduction of acrylic cement. The Tornier Cement Restrictor is used to prevent the cement progression in the diaphysis and therefore facilitate the cement pressurization during the introduction of the implant. Its flexible mechanism makes it adaptable to different diameters of medullary canal to be occluded. The present device modification submission consists in the addition of a small diaphyseal plug and an extension of the indication for use.

The CEMSTOP Cement Restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurization.

The CEMSTOP Cement Restrictor is inserted into the femoral canal prior to introduction of bone cement during total hip arthroplasty. It occludes the medullary canal and prevents the cement from flowing down the diaphysis and aids in cement pressurization. It is available in sizes. It is fabricated from gelatin and glycerol and is completely resorbed within a few days of implantation. The gelatin is porcine based.

The BioBuck™ Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

The BioBuck™ Cement Restrictor is a bioabsorbable version and modification of the Buck™ Cement Restrictor that was cleared for marketing by FDA on 27 June 1979 (K791125). The material for the BioBuck device is PolyActive®, a biocompatible copolyether. PolyActive is currently used to manufacture other cement restrictor devices (Shuttle Stop , K000587; SynPlug™ , K010840).

The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable bone cement flow restrictor for use in the intramedullary canal. This device is not intended for use in the spine.

The ImproVise™ Absorbable Cement Flow Restrictor is designed to provide a quick, simple, and effective method of plugging the intramedullary canal with an easy-to-place absorbable foam plug. Based on the size of the reamer used to form the channel, the appropriate size foam plug is selected and is then guided onto the tip of the tool. The ImproVise™ Insertion tool is then used to advance the plug down the canal to the desired depth, using the Cement Restrictor as a guide. The ImproVise™ foam plugs are deformable and bank against the irregular shape of the canal, effectively sealing the canal at the insertion point. The cement restrictors are available in sizes small, medium, large and extra-large (9.5-11 mm, 11-13 mm, 13-15 mm, 15-17.5 mm), both in straight cylindrical and tapered versions. The restrictor can be easily carved with a scalpel at the time of surgery, or press-fit into the bone. The ImproVise™ Absorbable Cement Flow Restrictor is manufactured from a proprietary polylactic acid foam, which is greater than 90% void space.

SynPlug™ is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

The proposed SynPlug™ cement restrictor is identical in intended use and fundamental scientific technology to the parent Shuttle Stop® cement restrictor that was cleared for marketing by FDA on May 4, 2000 (K000587). Design changes were made to prevent cement leakage and migration, increase pressure resistance, and improve the ease of handling of the cement restrictor. These design modifications are limited to the following: - Adoption of a cylindrical shape for the proposed SynPlug - Elimination of sidewall slots and addition of five flanges - Increase in the rigidity of the proposed device - Expansion of the number of available sizes for the proposed device to 13, designed to fit intramedullary canal diameters of 9 to 21 mm This submission also contains a description of instrumentation sets that have been developed to facilitate the selection of cement restrictor size by assessment of the intramedullary canal diameter and provide correct insertion of the cement restrictor. The SynPlug Instrumentation Set consists of 14 measuring probes for the measurement of canal diameters from 9 to 21 mm, two insertion rods, and a sterilization tray for holding the instruments during sterilization. The Shuttle Stop Instrumentation Set is identical to the SynPlug Instrumentation Set with the exception that only five measuring probes are provided to correspond with the four sizes of Shuttle Stop and a probe measuring the maximum intramedullary canal diameter for which the largest size Shuttle Stop can be used, 8 to 20 mm.

The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation.

The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation. Biocompatible, this device is completely resorbed within several days at 37 ℃ and resists the temporary temperature rise generated by polymerisation of acrylic cement. The CEMSTOP Cement Restrictor is available in diameters of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm and 20mm.

The indications for the use of the Osteonics® Universal Distal Hole Plug, in keeping with those of other legally marketed Osteonics accessory products for cemented arthroplasty, are as follows: For cement spacers, mid-shaft restrictors, distal plugs, and cement plugs: - In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

The Osteonics® Universal Distal Hole Plug is a single use component which is intended for optional use in cemented arthroplasties of the hip as determined by the physician. The Universal Distal Hole Plugs are manufactured from polymethylmethacrylate (PMMA) or PMMA mixed with Barium Sulfate (BaSO2) and are available in one universal size. The Universal Distal Hole Plug is cylindrical in shape, has a rounded distal tip, and flares very slightly from the proximal to The Universal Distal Hole Plug also employs a friction-fit design which secures it in distal end. the distal hole of any commercially available Osteonics® cemented hip stem. The Universal Distal Hole Plug is assembled to the hip stem intraoperatively and inserted into the femoral canal.

The Link femoral cement restrictor plug system is used to constrict the flow of bone cement (PMMA) into the distal section of the femoral canal during a cemented total hip arthoplasty.

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