MRI Information (Cranial Fixation) In accordance with ASTM F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, Biomet’s Cranial Fixation Devices should be labeled MR Conditional. Non-clinical testing has demonstrated that the Cranial Fixation Devices are MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions: Magnetic Field Interactions

Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T). Maximum spatial gradient field less than or equal to 30 T/m. Normal Operating Mode: Maximum whole-body specific absorption rate (SAR) of:

o 1.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0T. o 1.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5T.

3.0T RF heating In non-clinical testing with body coil excitation, the limiting device produced a total temperature rise of approximately 14.6ºC when exposed to a maximum specific absorption rate (SAR) of 3.4 W/kg for 15 minutes of scanning in a 3.0-Tesla MR system (Siemens Trio, SYNGO MR A35 4VA35A software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that SAR of 1.0 W/kg would be expected to yield a localized temperature rise of less than 4.5ºC in Normal Operating Mode. 1.5T RF heating In non-clinical testing with body coil excitation, the limiting device produced a total temperature rise of approximately 9.0 ºC when exposed to a maximum specific absorption rate (SAR) of 2.63 W/kg for 15 minutes of scanning in a 1.5-Tesla MR system (Siemens Espree, SYNGO MR B17 software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that SAR of 1.0 W/kg would be expected to yield a localized temperature rise of less than 3.5 ºC in Normal Operating Mode. Caution: The RF heating behavior does not scale with static field strength. Devices which do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength. MR Artifacts MR image quality may be compromised if the area of interest is the same or relatively close to the position of the device, and it may be necessary to optimize the MR imaging parameters. The shape of the expected artifact followed the approximate contour of the device and extended radially up to 3.6 cm from the implant gradient-echo images at 3.0 T in tests performed in accordance with ASTM F2119-07. The shape of the expected artifact followed the approximate contour of the device and extended radially up to 1.8 cm from the implant on gradient-echo images at 1.5T in tests performed in accordance with ASTM F2119-07. Other Magnetically induced displacement force and torque testing indicated that the implants posed no known risks with regard to displacement force and torque in the MRI environment.

Lorenz® Plating System Neuro

Note: Plate profile is 0.6mm unless otherwise noted. Plate dimensions are approximate.

4-Hole, MediumDouble T Plate

15mm01-7092

4-Hole, Wide Strut Square, 12mm0.5mm Thick

01-7357

4-Hole, Rectangle Plate, 18mm0.5mm Thick

01-7359

2 x 4-HoleRectangle Plate

25mm01-7137

3-HoleTriangle Plate

14mm01-7132

4-HoleSquare Plate

12mm01-7131

2 x 3-HoleRectangle Plate

18mm01-7136

4-Hole, LongDouble T Plate

18mm01-7093

Items to scale

4-Hole, RegularStraight Plate, 16mm

01-7040

16-Hole, Regular Straight Plate, 64mm01-7066

4-Hole, LongStraight Plate, 19mm

01-7047

6-Hole, Regular Straight Plate, 24mm

01-7050

4-Hole, MediumStraight Plate, 17mm

01-7045

4-Hole, X-LongStraight Plate, 20mm

01-7048

6-HoleOrbital Plate, 24mm

01-7126

2-Hole, MediumStraight Plate, 12mm

01-7345

2-Hole, LongStraight Plate, 16mm

01-7347

5-Hole, LongY Plate18mm

01-7102

5-Hole, Regular Y Plate16mm

01-7100

5-Hole, X-Long Y Plate19mm

01-7104

6-Hole, LongDouble Y Plate

16mm01-7112

4-HoleX Plate12mm

01-7120

6-Hole, RegularDouble Y Plate

15mm01-7110

6-Hole, X-LongDouble Y Plate

18mm01-7114

18.5mm Burr Hole Plate, 0.5mm Thick

01-7308

18.5mm Shunt Plate0.5mm Thick

01-7305

22mm Burr Hole Plate, 0.5mm Thick

01-7309

25mm Burr Hole Plate, 0.5mm Thick

01-7310

13mm Burr Hole Plate, 0.5mm Thick

01-7306

Neuro Implants

8-Hole Sub-Temporal Plate, 52mm01-7363

45mm Gap Plate01-7355

8-Hole Small Sub-Temporal Plate, 38mm01-7361

Note: Plate profile is 0.5mm

35mm Gap Plate01-7353

25mm Gap Plate01-7351

Panel, Small Grid

85mm x 53mm 0.6mm Thick

01-7182

85mm x 53mm 0.3mm Thick

01-7185

100mm x 100mm 0.3mm Thick

01-7188

Panel, Regular Grid

80mm x 53mm, 0.6mm Thick01-7180

85mm x 50mm0.2mm Thick

01-7340

1.0/1.5 Titanium Sheet

203mm x 127mm0.2mm Thick

01-7341

163mm x 115mm0.3mm Thick

01-7065

163mm x 115mm, 0.6mm Thick01-7069

40mm x 40mm0.6mm Thick

01-7017

40mm x 40mm0.3mm Thick

01-7019

1.5mm Ultra Pre-Contoured Mesh (pattern same as above)

1.5mm Contourable Mesh

100mm x 100mm0.6mm Thick

01-7249

206mm x 123mm0.3mm Thick

01-7250

206mm x 123mm0.6mm Thick

01-7251

Note: Partial view of actual size shown

Note: Specialty Plates developed through Rapid Response DepartmentItems to scale

85mm x 55mm,0.3mm Thick

SP-1841

Specialty Plates

Shunt Plate, 18.5mm,0.5mm Thick

SP-1528

Shunt Plate, 25mm,0.5mm Thick

SP-2321

Retrosigmoid Plates, 0.3mm Thick

Small45mm x 37mm

SP-1842

Large54mm x 45mm

SP-1798

Specialty Plates not to scale

Small, 52mm x 40mm

0.3mm ThickSP-1836

0.3mm ThickMalleableSP-2090

0.6mm ThickSP-1796

Large, 59mm x 45mm

0.3mm ThickSP-1837

0.3mm ThickMalleableSP-2087

0.6mm ThickSP-1797

Translabyrinthine Plates

Shunt Plates

Small, 41mm x 39mmLeft: SP-2250 Right: SP-2249

Medium, 48mm x 45mmLeft: SP-2139 Right: SP-2138

Large, 53mm x 48mmLeft: SP-2136 Right: SP-2135

*Left shown

Retromastoid Plate, 0.3mm Thick

Chiari Plates 0.6mm Thick

Small42mm x 30mm

SP-1343

Large55mm x 38mm

SP-2082

Triangle, 43mm x 48mmSP-2281

Neuro Screws & InstrumentsNeuro Screws & Instruments

3-Prong Bender01-7167

Plate Bending Plier01-7465

Plate/Wire Cutter01-7172

Neuro Plate Holding Wand01-7189

Beuse Plate Holding Forceps01-9095

Instrumentation1.5mm Self-Drilling Screws (5pk)

1.0mm3.5mm Stop

01-7143

1.0mm5mm Stop01-7145

1.1mm5mm Stop01-7139

3.5mm Stop01-7141

5mm Stop01-7142

Hall Drills

3.5mm Stop01-7393

5mm Stop01-7395

Black Max Drill

1.1 x 104mm, 5mm Stop01-7394

Midas Rex Drills

J-Notch Drills

Hand Drills

3.5mm Stop15-1723

Twist Drills & Handles

5mm Stop15-1725

Part # 95-610395-610495-610591-XXXX

Description Self-Drilling HT X-Drive Screw 1.5 x 3.5mmSelf-Drilling HT X-Drive Screw 1.5 x 4mmSelf-Drilling HT X-Drive Screw 1.5 x 5mmFor Single Screws

Green Screwdriver Handle01-7390

Standard Screwdriver Handle01-7164

1.5mm Screws (5pk)95-150395-150495-150595-180395-180591-XXXX

HT X-Drive 1.5 x 3.5mmHT X-Drive 1.5 x 4mmHT X-Drive 1.5 x 5mmHT X-Drive Emergency Screw 1.8 x 3.5mmHT X-Drive Emergency Screw 1.8 x 5mmFor Single Screws

Items not to scale

HT X-Drive Screws and Blades

1.5mm HT X-Drive Blades15-119615-119450-1015

1.5 HT X-Lock Standard1.5 HT X-Lock Short1.5mm HT X-Lock Power Driver Blade

1.5mm Self-Drilling Screws (5pk)

Part # 01-728301-728401-728599-XXXX

Description SD Center-Drive Screw 1.5 x 3.5mmSD Center-Drive Screw 1.5 x 4mmSD Center-Drive Screw 1.5 x 5mmFor Single Screws

1.5mm Center-Drive Screws (5pk)01-720301-720401-720501-722301-722599-XXXX

Center-Drive 1.5 x 3.5mmCenter-Drive 1.5 x 4mmCenter-Drive 1.5 x 5mmCenter-Drive Emergency Screw 1.8 x 3.5mmCenter-Drive Emergency Screw 1.8 x 5mmFor Single Screws

Center-Drive Screws and Blades

1.5mm HT X-Drive Blades01-717601-7171

1.5 Center-Drive Standard1.5 Center-Drive Short

1.1 x 50mm

1.1 x 67mm Hex Drill

1.0/1.1 x 38mm

1.1 x 87mm