AccuFill® Bone Substitute Material (BSM)for The Subchondroplasty® (SCP®) Procedure

A Truly Injectable CaP that Fills SubchondralDefects Without Cavity Creation

AccuFill® BSM Standard “Injectable” BSM

Not for Distribution; for Internal Use Only.

Bone Substitute Material Competitive Matrix

Cancellous Bone AccuFill® BSM HydroSet™ 1,2,3,4 PRO-DENSE® 4,5 QuickSet™† 4,6 Strucsure™ CP‡ 4,6 InjectionPlasty™ 1.0 1,2,7 BoneSource™ BVF 1,2,8

Manufactured/ Distributed By: ETEX/Zimmer Knee Creations Stryker Wright Medical

†Arthrex ‡Smith & Nephew

Skeletal Kinetics Stryker

Formulation Natural apatite Engineered apatite Apatite 75% CaP25% CaS Engineered apatite Engineered apatite Apatite

Injectability/Flow (into closed fracture) N/A +++

+/-Requires surgically-created/

traumatic void

-Requires surgically-

created/traumatic void++ +

Requires surgically-created/

traumatic void

Handling Properties

N/A Working Time: 15 min Working Time: 4.5 min Working Time: 3-5 min Working Time: 2 min Working Time: 4 min Working Time:30-60 seconds

N/A Setting Time: 10 min Setting Time: 4 min; fully @ 24 hrs Setting Time: 20-30 min Setting Time: ~24 hrs Setting Time: 24 hrs Setting Time: 5-10 min;

fully @ 2 wks

N/A

AccuMix® mixing syringe; mix with saline or blood; direct transfer to delivery

syringes

Bowl mix; pour into delivery syringe or manual application

Mixer system with crank delivery

Closed system that transfers and mixes; no extra solution if

some is lost

Closed, crank mixer; one-syringe injection; Jamshidi-type cannula

Bowl mix; pour into delivery syringe or manual application

Structure/ Compressive

Strength

Porosity: overall 70%;highly macro-porous

Porosity: overall 65%;highly macro-porous

Porosity: 3%; mostly closed pores Porosity: rapidly changing Porosity: overall 66%;

10% macro-porousLow porosity; larger crystals Low porosity

10 MPa9 10 MPa 10-15 MPa 40 MPa initially; decreases rapidly 24 MPa 33-50 MPa 17 MPa

Remodel/ Resorption Cell-mediated remodeling Cell-mediated remodeling No/slow resorption Rapid dissolution Cell-mediated remodeling No/slow resorption No/slow resorption

References1. HydroSet Literature - Stryker 2008 90-07900 LOT B1008; HydroSet Literature - Stryker 2006 LHS-B MS/GS 3C 08/06; HydroSet Literature - Stryker 2006 LHS-SS MS/GS 3C 08/06 http://

literature.ortho.stryker.com/files/LHS_SS.pdf2. Larson 2006 Injectable Phosphate Cements – A Review3. Van Lieshout et al. BMC Musculoskeletal Disorders 2011, 12:344. Colon, et al. “Assessment of the injection behavior of commercially available bone BSMs for Subchondroplasty® procedures”, The Knee 2015; 021125. PRO-DENSE® Bone Graft Substitute Mixing Instructions 135703-3; PRO-DENSE® Bone Graft Substitute 133486-10 IFU; ProDense Product guide _ Ortotech Access 2014-05-28; Wright

Medical Product Guide for Bone Graft Substitutes & Soft Tissue Repair SK908-1212; ProDense Website; Wright Medical; 2014

Cancellous Bone AccuFill® BSM HydroSet™ 1,2,3,4 PRO-DENSE® 4,5 QuickSet™† 4,6 Strucsure™ CP‡ 4,6 InjectionPlasty™ 1.0 1,2,7 BoneSource™ BVF 1,2,8

Manufactured/ Distributed By: ETEX/Zimmer Knee Creations Stryker Wright Medical

†Arthrex ‡Smith & Nephew

Skeletal Kinetics Stryker

Formulation Natural apatite Engineered apatite Apatite 75% CaP25% CaS Engineered apatite Engineered apatite Apatite

Injectability/Flow (into closed fracture) N/A +++

+/-Requires surgically-created/

traumatic void

-Requires surgically-

created/traumatic void++ +

Requires surgically-created/

traumatic void

Handling Properties

N/A Working Time: 15 min Working Time: 4.5 min Working Time: 3-5 min Working Time: 2 min Working Time: 4 min Working Time:30-60 seconds

N/A Setting Time: 10 min Setting Time: 4 min; fully @ 24 hrs Setting Time: 20-30 min Setting Time: ~24 hrs Setting Time: 24 hrs Setting Time: 5-10 min;

fully @ 2 wks

N/A

AccuMix® mixing syringe; mix with saline or blood; direct transfer to delivery

syringes

Bowl mix; pour into delivery syringe or manual application

Mixer system with crank delivery

Closed system that transfers and mixes; no extra solution if

some is lost

Closed, crank mixer; one-syringe injection; Jamshidi-type cannula

Bowl mix; pour into delivery syringe or manual application

Structure/ Compressive

Strength

Porosity: overall 70%;highly macro-porous

Porosity: overall 65%;highly macro-porous

Porosity: 3%; mostly closed pores Porosity: rapidly changing Porosity: overall 66%;

10% macro-porousLow porosity; larger crystals Low porosity

10 MPa9 10 MPa 10-15 MPa 40 MPa initially; decreases rapidly 24 MPa 33-50 MPa 17 MPa

Remodel/ Resorption Cell-mediated remodeling Cell-mediated remodeling No/slow resorption Rapid dissolution Cell-mediated remodeling No/slow resorption No/slow resorption

6. Strucsure Literature - Smith & Nephew 10601037 Rev. A; Strucsure Surgical Technique - S&M 2011 7118-2017 REV0 06_11; Arthrex Brochure, 20127. InjectionPlasty Literature; Skeletal Kinetics Website; 2014; InjectionPlasty Sales Training, 20148. Stryker Website; 2014; BoneSource BVF Lit - Stryker 2004 LBVFB GC CS 7.5M 05_049. Keaveny, et al. “Bone Mechanics”, Standard Handbook of Biomedical Engineering and Design, McGraw-Hill, 2004, Chap. 8, p11-12.

All trademarks protected as registered with their respective companies.

Not for Distribution; for Internal Use Only.

AccuFill® BSM Features and Benefi ts• Injectable Calcium Phosphate (CaP)• Flows readily; fi lls subchondral bone defects without cavity creation• Mimics properties of normal cancellous bone• Undergoes cell-mediated remodeling; resorbed and replaced as the bone heals

subchondroplasty.com903.029 Rev. B | Copyright © 2016 Zimmer Knee Creations, Inc.

MANUFACTURED BY:ETEX675 Mass. Ave, 12th FloorCambridge, MA 02139www.etexcorp.com

CRITERIA FEATURE BENEFIT

Formulation Ca10-x(M)x(PO4)6-x(HPO4,CO3)x(OH)2-x

[(M)=metal ions (e.g. Mg++)]• Mimics chemical structure of natural bone• Facilitates remodeling

Working Time 15 minutes in the OR• Provides long working time before implantation• Maintains “paste” form throughout

Handling, Mixing Readily mixes in AccuMix® Syringe• User friendly• No loss of BSM during mix or transfer• Can be mixed with blood or saline

Injectability Injectable under low pressure;no phase separation

• Requires only digital pressure to inject

Flowability Flows uniformly; no phase separationinto cancellous bone

• No need for surgical void creation, preserves healthy bone• Allows for complete defect fi ll

Irrigatability Hydrophilic; soluble in synovial fl uid • Irrigates easily if extravasation into joint space occurs

Setting Time Endothermically sets in 10 minutes at 37°C• Sets hard after closure• No thermal necrosis

Porosity 65% total porosity (interconnected); 1-300 µm• High surface area facilitates remodeling and bony ingrowth• Facilitates fl uid transfer through the material

Crystalline Structure Amorphous, nanocrystalline; 6 µm average size

• Mimics natural cancellous bone• Supports normal bone metabolism and remodeling

Compressive Strength ~10 MPa • Properties comparable to cancellous bone*

Bioactivity Interdigitates in bone; osteoconductive• Sets hard and maintains shape• Provides continuous osteoconductive scaffold

Remodeling Cell-mediated remodeling • Remodels with new bone growth

Drillability Drillable during and after setting • Procedural fl exibility

*Keaveny, et al, “Bone Mechanics”, Standard Handbook of Biomedical Engineering and Design, McGraw-Hill, 2004, Chap. 8, p11-12.

Zimmer Knee Creations, Inc.841 Springdale DriveExton, PA 19341

Customer Service: 1-855-SCP-5818kc.customerservice@zimmerbiomet.com