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Ordering InformationAdditional plug sizes are available for use with othercommercially available osteochondral transplant systems(see implant systems). The TRUFIT Plug kit contains one ofeach of the following:

• Cylindrical Implant, 18 mm long• Delivery Device (outer sleeve and measuring tamp)• Trimming Knife

TRUFIT CB Plug Kits72200930 TRUFIT CB Plug Kit Green (5 mm)72200931 TRUFIT CB Plug Kit Yellow (6 mm)72200932 TRUFIT CB Plug Kit Red (7 mm)72200933 TRUFIT CB Plug Kit Tan (7.5 mm)72200934 TRUFIT CB Plug Kit Blue (9 mm)72200935 TRUFIT CB Plug Kit Orange (9.5 mm)72200936 TRUFIT CB Plug Kit Purple (11 mm)

Note: Numeric sizes indicated under manufacturer’s name refer to the instrumentation size labeled by themanufacturer. Smith & Nephew’s numeric sizes do not correspond to each manufacturer’s sizing. The TRUFITCB Plug is uniquely sized for a tight interference fit. Please refer to this chart for all sizing compatibility.

TRUFIT™ CB PlugSize Code (diameter) Arthrex OATS™ Mitek COR® Smith & Nephew

MOSAICPLASTY™

Green (5 mm) 4

Yellow (6mm) 4.5

Red (7 mm) 6 6

Tan (7.5 mm) 6.5

Blue (9mm) 8

Orange (9.5 mm) 8 8.5

Purple (11 mm) 10

Kit Components1. TRUFIT CB Plug

2. Delivery Devicea. Measuring Tampb. Outer Sleeve

3. Trimming Knife

Not to scale

2a

2b1

3

Implant Systems

You fill the void, nature does the rest

TRUREPAIR™ Solutions

The Smith & Nephew TRUFIT™ CB Plug is a cylindrical scaffold designed torepair cartilage and bone in osteochondral defects left by surgery, trauma or disease. Made with Smith & Nephew POLYGRAFT™ technology — aproprietary, composite material with mechanical properties that mimic thoseof surrounding tissue layers — the TRUFIT CB Plug provides a mechanicallystable environment with a porous nature that provides conduits for tissueingrowth. Each kit is packaged with a TRUFIT CB Plug, delivery device andtrimming knife to allow implantation of the plug arthroscopically or through a mini-arthrotomy based on surgeon preference and defect location.

Intended UseThe TRUFIT CB Plug is intended to serve as a support for cellular and matrix ingrowth inosteochondral defect repair such as cartilage and/or bone, that is not intrinsic to the stability of the bone. The device is a resorbable tissue regeneration scaffold for use in the treatment of acute focal articular cartilage or osteochondral defects. The product is provided sterile for singlepatient use and for implantation into precisely created defects. TRUFIT CB Plug can also be used torepair osteochondral defects created during autogenous osteochondral transfer procedures. Pleaseuse the size chart to determine the appropriately sized TRUFIT CB Plugs for other commerciallyavailable instrument systems.

• Cylindrical implant is press-fit into the site for close apposition,encouraging migration of repairtissue.

• Interconnected pores (meandiameter of 250 μ) enhancetissue ingrowth and remodeling.

• Hydrophilic properties absorbblood, marrow, cells and proteinson implantation.

• Scaffold can be finely contouredat the time of surgery.

• Plug completely resorbs in 6–9 months.

• Offered in 5 mm (green), 7 mm (red), 9 mm (blue), and 11 mm (purple) to correspond to Smith & Nephew TRUKOR™ PlusSite Preparation Kit.

9 mm TRUFIT CB Plug immediately postimplantation in medial femoral condyle. Note: Blood has wicked into scaffold.

TRUFIT CB Plug 21 months afterimplantation. Note complete plugintegration and defect coverage with normal thickness hyaline-like cartilage.Small amount of fibrillation due to meniscal tear.

Biopsy (stained with Safranin 0/FastGreen) 21 months after TRUFIT CB PlugImplantation demonstrating healing with hyaline-like cartilage andsubchondral bone.

Clinical Case Report

Assembly

Once the implant has been cut to a flatsurface, the delivery device is used toinsert the implant into the defect. Slightlyadvance the implant beyond the tip of theouter sleeve.

Insert the measuring tamp of the deliverydevice into the defect, ensuring that itcontacts the bottom of the defect.

Slide the outer sleeve down until the lip ofthe outer sleeve is snugly placed againstthe surface of the tissue (this automaticallyadjusts the implant to the correct positionfor trimming), then carefully remove thedelivery device from the surgical site.

Firmly grip the outer sleeve at the windowsto secure the implant during cutting.Steady the hand and delivery deviceagainst a table or other sterile surface.Using the lip of the delivery device as aguide, cut the notched end of the implantwith the trimming knife using a firmdownward motion.

If the implant needs further adjustment orcontouring, separate the measuring tampfrom the outer sleeve and use the tamp toimpact the implant. The final placement ofthe implant should be flush with theadjacent surface.

Implant Placement

Carefully seat the implant in the defect andpress fit into the defect by pushing on themeasuring tamp manually or lightly tampingwith a mallet. Remove the delivery devicefrom the surgical site.

4 5

6 7 8

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At this point, the implant should not extendbeyond the delivery device.

To assemble the Smith & Nephew TRUFITDelivery Device, insert the measuring tampinto the outer sleeve in the direction of thearrow on the outer sleeve until contact withthe preloaded implant is made.

Note: If implantbecomes dislodgedfrom deliverydevice, reload intothe window end ofthe outer sleevewith the notchedend of the implantfacing outward.

Surgical Technique: Osteochondral Repair

Implant Length Adjustment

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Note: Cautionshould be taken notto nick the top ofthe outer sleeve ofthe delivery device.