IMPROVING LIVES ONE ALLOGRAFT AT A TIME.

PRODUCT CATALOG 2014 – 2015

CONTENTS

Introduction

About Pinnacle Transplant Technologies........................................................................ 3

Process

Donor Screening................................................................................................................. 4 1125 W. Pinnacle Peak Rd., Bldg. #2 Phoenix, Arizona 85027 PHONE 623-277-5400 FAX 623-277-5401 [email protected]

www.pinnacletransplant.com

Testing.................................................................................................................................. 5 Sterilization.......................................................................................................................... 5 Quality Systems.................................................................................................................. 5

Products

Cancellous Chips................................................................................................................ 6 Fascia Lata........................................................................................................................... 6 Femur................................................................................................................................... 7 Fibula.................................................................................................................................... 7 Ilium...................................................................................................................................... 7 Matchsticks.......................................................................................................................... 7 Tendons................................................................................................................................ 8 DBM...................................................................................................................................... 8 Costal Cartilage.................................................................................................................. 9 Specialty Spine: Lumbar.................................................................................................... 9 Specialty Spine: Cervical...........................................................................................10–12

INTRODUCTION

ABOUT

Pinnacle Transplant Technologies

Founded in 2010, Pinnacle Transplant Technologies (PTT) recognized the need to establish a processing and distribution facility that would enable medical professionals to acquire safe quality allograft tissue for transplant. We manufacture innovative allografts produced to the highest standards of quality and safety. With a dedication to customer service, we are devoted to being the most responsive and accommodating Tissue Bank in the industry. PTT is a multi-service tissue bank dedicated to the ethical participation in the Donate Life™ process. U.S. Food and Drug Administration (FDA) registered and American Association of Tissue Banks (AATB) accredited, Pinnacle only works with federally chartered Organ Procurement Organizations (OPOs) and agencies accredited by AATB to help provide superior allografts for transplantation, assure transplant patient safety, safeguard our associates, and assure reverence to our donor families. Located in Phoenix, Arizona, PTT’s newly constructed 24,000 square foot processing facility was designed by tissue banking experts to meet the specific demands of our industry. PTT’s processing core contains 10 validated cleanrooms, fully appointed with state-of- the-art equipment, including multiple CNC precision milling machines for processing machined specialty allografts.

Our cleanroom environment is

continuously monitored and alarmed for temperature, humidity and differential pressure to ensure optimal processing conditions. PTT’s management team and experienced work force have extensive tissue banking experience and have been actively involved in producing thousands of quality orthopedic and spinal allografts for transplantation.

Product Catalog I 3

PROCESS

DONOR SCREENING

PTT’s Quality Systems and validated processes ensures patient safety from the initial donor consultation to the surgeon’s transplantation of a PTT allograft. PTT is contracted with federally licensed Organ Procurement Organizations (OPO) and agencies accredited by the American Association of Tissue Banks (AATB) for the procurement of donor tissue. PTT is an active partner with the National Donate Life™ Organization, and work closely with our local Donate Life™ Arizona team. We diligently promote organ donation through ethical encouragement. ►► Comprehensive medical and social histories are thoroughly reviewed by trained, qualified personnel on every donor. ►► PTT’s donor acceptance criteria are established and maintained by our Medical Director. ►► PTT’s’ donor acceptance criteria are established and maintained by a Medical Review Board. ►► Recovery technicians are trained by their respective agencies, receiving continuing education to assure the consistent knowledge and application of PTT’s’ strict donor acceptance standards. ►► PTT has strict standard operating procedures and protocols. Our Quality Systems personnel routinely audit our recovery partners, ensuring compliance. ►► PTT only receives cadaveric tissue from not-for-profit OPOs and recovery agencies.

Product Catalog I 4

PROCESS

TESTING

All tissue and blood samples are tested for infectious diseases by a CLIA Certified Lab. Our comprehensive battery of testing includes: HBsAG: Hepatitis B Surface Antigen, HBcAb: Hepatitis B Core Antibody, HCVAb: Hepatitis C Antibody, HIV1/2/ Ab: Human Immunodeficiency Virus Types 1/2 and O Antibody, HCV NAT: Hepatitis C Virus, HIV NAT: Human Immunodeficiency Virus Types 1/2 and O Antibody, HBV NAT: RPR/STS or Equivalent: Syphilis. As an accredited member of the American Association of Tissue Banks (AATB), all of our testing and processing of donated tissue meet or exceed all AATB standards and FDA regulations. All test results are evaluated by a team of specialists and physicians from the infectious disease, pathology and tissue banking fields. * Tested using FDA required test kits

STERILIZATION

PTT allografts are terminally sterilized via low dose gamma irradiation. The dose used to sterilize all tissue was determined by performing a VDMAX validation and is verified on a quarterly basis. All allograft tissue has a Sterility Assurance Level (SAL) of 10-6

QUALITY SYSTEMS

PTT’s Quality Systems meet or exceed all FDA regulations, AATB standards and federally mandated Current Good Tissue Practice guidelines. Our allografts are processed under strict aseptic practices and subject to multiple inspections, measurements and packaging reviews to insure the quality and safety of our products. Our Quality Systems personnel are highly educated, experienced and knowledgable of the tissue banking industry. We promote attendance at AATB sponsored meetings and seminars. PTT encourages all of our personnel to achieve the status of Certified Tissue Banking Specialist (CTBS).

Product Catalog I 5

PRODUCTS

PTT produces its own proprietary products and specializes in contract manufacturing and private label.

CANCELLOUS CHIPS

FASCIA LATA

Product Code Description

Size

CCH-1410

Cancellous Chips Crushed 1-4mm

10cc

CCH-1415

Cancellous Chips Crushed 1-4mm

15cc

CCH-1430

Cancellous Chips Crushed 1-4mm

30cc

CCH-1460

Cancellous Chips Crushed 1-4mm

60cc

CCH-41015

Cancellous Chips 4-10 mm

15cc

CCH-41030

Cancellous Chips 4-10 mm

30cc

CCH-41060

Cancellous Chips 4-10 mm

60cc

CCH-41090

Cancellous Chips 4-10 mm

90cc

MIX-01

Cortical Cancellous Chips

1cc

MIX-05

Cortical Cancellous Chips

5cc

MIX-15

Cortical Cancellous Chips

15cc

MIX-30

Cortical Cancellous Chips

30cc

Product Code Description

Size

FL-11

Fascia Lata Medium (Freeze Dried)

120mm

Product Catalog I 6

PRODUCTS

FEMUR

FIBULA

ILIUM

MATCHSTICKS

Product Catalog I 7

Product Code Description

Size

FED-11

Shaft

120mm

FH-50

Femoral Head

N/A

Product Code Description

Size

FID-11

Distal

N/A

FISSE-3

Shaft Segment

50mm

FISS-4

Shaft Segment

100mm

FIR-11

Ring

>1.5cm

Product Code Description

Size

ICW-08

Iliac Crest wedge Parallel

8mm

ICW-10

Iliac Crest wedge Parallel

10mm

ICW-12

Iliac Crest wedge Parallel

12mm

ICW-14

Iliac Crest wedge Parallel

14mm

ICW-16

Iliac Crest wedge Parallel

16mm

ICW-18

Iliac Crest wedge Parallel

18mm

ICW-20

Iliac Crest wedge Parallel

20mm

Product Code Description

Size

CST-22

Cortical Strips

5x50, 5pk

CCS-49

Cortical Cancellous Strips

50mm, 5pk

PRODUCTS

TENDONS

DBM

Product Code Description

Size

ACT-11

Achilles Tendon

N/A

PH-11

Patella-Hemi

N/A

PW-11

Patella-Whole

N/A

GR-11

Gracilis

N/A

ST-11

Semitendinosis

N/A

GSTP-11

Gracilis/Semi-T pair

N/A

ATBT-11

Anterior Tibialis

N/A

PTT-11

Posterior Tibialis

N/A

PL-11

Peroneus Longus

N/A

Product Code Description

Size

DBM-SBL-10

DBM Sponge Block

10x10x10mm

DBM-SBL-12

DBM Sponge Block

12x12x12mm

DBM-SBL-14

DBM Sponge Block

14x14x14mm

DBM-SS-30

DBM Sponge Strip

35x20x7mm

DBM-SS-35

DBM Cancellous Strip

50x20x7mm

DBM-CCH-02

DBM Cancellous Chips

2cc

DBM-CCH-05

DBM Cancellous Chips

5cc

DBM-CCH-10

DBM Cancellous Chips

10cc

PTT-DBM-01P

DBM Putty

1.0cc

PTT-DBM-02P

DBM Putty

2.5cc

PTT-DBM-05P

DBM Putty

5cc

PTT-DBM-10P

DBM Putty

10cc

Product Catalog I 8

PRODUCTS

Costal Cartilage

SPECIALTY SPINE

LUMBAR

Product Catalog I 9

Product Code Description

Size

RB 28

Costal Cartilage 2.8-3.49cm

N/A

RB 38

Costal Cartilage 3.5-4.9cm

N/A

RB 50

Costal Cartilage ≥5.0cm

N/A

Product Code Description

Size

PLIF-7

PLIF 7

7mm

PLIF-9

PLIF 9

9mm

PLIF-11

PLIF 11

11mm

PLIF-13

PLIF 13

13mm

PLIF-15

PLIF 15

15mm

ALIF-1208

8 degree ALIF

12mm 8 degree lordosis

ALIF-1408

8 degree ALIF

14mm 8 degree lordosis

ALIF-1608

8 degree ALIF

16mm 8 degree lordosis

ALIF-1808

8 degree ALIF

18mm 8 degree lordosis

ALIF-2008

8 degree ALIF

20mm 8 degree lordosis

ALIF-1212

12 degree ALIF

12mm 12 degree lordosis

ALIF-1412

12 degree ALIF

14mm 12 degree lordosis

ALIF-1612

12 degree ALIF

16mm 12 degree lordosis

ALIF1812

12 degree ALIF

18mm 12 degree lordosis

ALIF-2012

12 degree ALIF

20mm 12 degree lordosis

PRODUCTS

SPECIALTY SPINE CERVICAL

Product Code Description

Size

PTT-CVCS-05

Convex Cervical Spacer

5mm

PTT-CVCS-06

Convex Cervical Spacer

6mm

PTT-CVCS-07

Convex Cervical Spacer

7mm

PTT-CVCS-08

Convex Cervical Spacer

8mm

PTT-CVCS-09

Convex Cervical Spacer

9mm

PTT-CVCS-10

Convex Cervical Spacer

10mm

AC-06L

Assembled Cervical Lordotic (Saline)

6mm

AC-07L

Assembled Cervical Lordotic (Saline)

7mm

AC-08L

Assembled Cervical Lordotic (Saline)

8mm

AC-09L

Assembled Cervical Lordotic (Saline)

9mm

AC-10L

Assembled Cervical Lordotic (Saline)

10mm

AC-11L

Assembled Cervical Lordotic (Saline)

11mm

AC-12L

Assembled Cervical Lordotic (Saline)

12mm

PTT-PCCS-L05S

LG Parallel Cortical Cervical Spacer (Saline)

5mm

PTT-PCCS-L06S

LG Parallel Cortical Cervical Spacer (Saline)

6mm

PTT-PCCS-L07S

LG Parallel Cortical Cervical Spacer (Saline)

7mm

PTT-PCCS-L08S

LG Parallel Cortical Cervical Spacer (Saline)

8mm

PTT-PCCS-L09S

LG Parallel Cortical Cervical Spacer (Saline)

9mm

PTT-PCCS-L10S

LG Parallel Cortical Cervical Spacer (Saline)

10mm

PTT-LCCS-L05S

LG Lordotic Cortical Cervical Spacer (Saline)

5mm

PTT-LCCS-L06S

LG Lordotic Cortical Cervical Spacer (Saline)

6mm

PTT-LCCS-L07S

LG Lordotic Cortical Cervical Spacer (Saline)

7mm

PTT-LCCS-L08S

LG Lordotic Cortical Cervical Spacer (Saline)

8mm

PTT-LCCS-L09S

LG Lordotic Cortical Cervical Spacer (Saline)

9mm

PTT-LCCS-L10S

LG Lordotic Cortical Cervical Spacer (Saline)

10mm

CONTINUED ON NEXT PAGE

Product Catalog I 10

PRODUCTS

SPECIALTY SPINE CERVICAL (CONTINUED)

Product Catalog I 11

Product Code Description

Size

PTT-LCCCS-05

Cortical Cancellous Cervical Spacer Lordotic

5mm

PTT-LCCCS-06

Cortical Cancellous Cervical Spacer Lordotic

6mm

PTT-LCCCS-07

Cortical Cancellous Cervical Spacer Lordotic

7mm

PTT-LCCCS-08

Cortical Cancellous Cervical Spacer Lordotic

8mm

PTT-LCCCS-09

Cortical Cancellous Cervical Spacer Lordotic

9mm

PTT-LCCCS-10

Cortical Cancellous Cervical Spacer Lordotic

10mm

PTT-LCCS-05

Cortical Cervical Spacer Lordotic

5mm

PTT-LCCS-06

Cortical Cervical Spacer Lordotic

6mm

PTT-LCCS-07

Cortical Cervical Spacer Lordotic

7mm

PTT-LCCS-08

Cortical Cervical Spacer Lordotic

8mm

PTT-LCCS-09

Cortical Cervical Spacer Lordotic

9mm

PTT-LCCS-10

Cortical Cervical Spacer Lordotic

10mm

PTT-LCCS-05S

Lordotic Cortical Cervical Spacer (Saline)

5mm

PTT-LCCS-06S

Lordotic Cortical Cervical Spacer (Saline)

6mm

PTT-LCCS-07S

Lordotic Cortical Cervical Spacer (Saline)

7mm

PTT-LCCS-08S

Lordotic Cortical Cervical Spacer (Saline)

8mm

PTT-LCCS-09S

Lordotic Cortical Cervical Spacer (Saline)

9mm

PTT-LCCS-10S

Lordotic Cortical Cervical Spacer (Saline)

10mm

PTT-PCCS-05S

Parallel Cortical Cervical Spacer (Saline)

5mm

PTT-PCCS-06S

Parallel Cortical Cervical Spacer (Saline)

6mm

PTT-PCCS-07S

Parallel Cortical Cervical Spacer (Saline)

7mm

PTT-PCCS-08S

Parallel Cortical Cervical Spacer (Saline)

8mm

PTT-PCCS-09S

Parallel Cortical Cervical Spacer (Saline)

9mm

PTT-PCCS-10S

Parallel Cortical Cervical Spacer (Saline)

10mm

PRODUCTS

SPECIALTY SPINE CERVICAL (CONTINUED)

Product Code Description

Size

PTT-PCCS-05

Cortical Cervical Spacer Parallel

5mm

PTT-PCCS-06

Cortical Cervical Spacer Parallel

6mm

PTT-PCCS-07

Cortical Cervical Spacer Parallel

7mm

PTT-PCCS-08

Cortical Cervical Spacer Parallel

8mm

PTT-PCCS-09

Cortical Cervical Spacer Parallel

9mm

PTT-PCCS-10

Cortical Cervical Spacer Parallel

10mm

PTT-PCCCS-05

Cortical Cervical Spacer (Can)(P)

5mm

PTT-PCCCS-06

Cortical Cervical Spacer (Can)(P)

6mm

PTT-PCCCS-07

Cortical Cervical Spacer (Can)(P)

7mm

PTT-PCCCS-08

Cortical Cervical Spacer (Can)(P)

8mm

PTT-PCCCS-09

Cortical Cervical Spacer (Can)(P)

9mm

PTT-PCCCS-10

Cortical Cervical Spacer (Can)(P)

10mm

Product Catalog I 12

For More Information Please Contact Pinnacle Transplant Technologies

1125 W. Pinnacle Peak Rd., Bldg. #2 I Phoenix, Arizona 85027 (P) 623-277-5400 I (F) 623-277-5401 [email protected]

www.pinnacletransplant.com