A DVANC ED BON E G RAF T

SYSTEM OVERVIEW
NANOSS BIOACTIVE | ADVANCED BONE GRAFT

Table Of Contents
INTRODUCTION

System Overview ............................................................................................................................................................................ 1

NANOSS BIOACTIVE COMPONENTS

Comparison of nanOss Bioactive and Human Bone .......................................................................................................................... 1

CLINICAL

Clinical Application ......................................................................................................................................................................... 2

nanOss Bioactive Spinal Fusion Study ............................................................................................................................................. 2

ORDERING INFORMATION

nanOss Bioactive ............................................................................................................................................................................. 3

nanOss Bioactive Loaded ................................................................................................................................................................ 3

INDICATIONS & WARNINGS

nanOss Bioactive Indications, Contraindications, Warnings, Precautions .......................................................................................... 4

nanOss Bioactive Loaded Indications, Contraindications, Warnings, Precautions .............................................................................. 4

NANOSS BIOACTIVE
 SYSTEM OVERVIEW

NANOSS BIOACTIVE SYSTEM OVERVIEW

nanOss Bioactive advanced bone graft combines a collagen-based biopolymer and nanocrystalline hydroxyapatite that mimic
the structure of bone to give a natural bone growth solution.

INTRODUCTION
The bioscaffold carrier provides an ideal cellular environment for bone repair. The advanced carrier in nanOss Bioactive
utilizes a patented process to open collagen’s triple helical structure to form an open bioscaffold for tissue infiltration. Host
cells interact with the open bioscaffold carrier that provides an ideal environment for bone formation.

Traditional closed collagen carrier nanOss Bioactive open structure

COMPARISON OF NANOSS BIOACTIVE AND HUMAN BONE: NANOSS BIOACTIVE IS SYNTHETIC BONE

Human Bone nanOss Bioactive

COMPONENTS
8%
Bone Composition:
Contains Hydroxyapatite 60% hydroxyapatite 32%
and Collagen 32% collagen 60%
8% water

nanOss Bioactive’s osteoconductive scaffold is

composed of nano-sized hydroxyapatite crystals
Contains interconnected that are the same size, composition and shape
porosity as human bone. These similarities allow the
body to recognize nanOss Bioactive as bone and
effectively remodel this graft into new bone.

Equivalent crystal size

25-500 nm 15-100 nm Optimal size for tissue interaction
and structure

High surface area increases attachment and

replication of bone forming cells and improves
High surface area 100 m /g
2
70 m /g
2
mineralization, leading to remodeling of nanOss
Bioactive into the patient’s own bone.

ADVANCED BONE GRAFT 1

 NANOSS BIOACTIVE | ADVANCED BONE GRAFT

CLINICAL APPLICATION
CLINICAL

11 weeks post surgery x-ray of tibial plateau fracture repaired with nanOss Bioactive.

1-year CT image of patient treated with nanOss

Bioactive combined with bone marrow aspirate and
local bone graft across the transverse process.

NANOSS BIOACTIVE SPINAL FUSION STUDY

• L5-L6 Posterolateral Fusion in rabbit

• 12 Week Duration
• 3 Treatment Groups
nanOss Bioactive Granule
› nanOss Bioactive + Bone Marrow Aspirate +
Autograft New Bone
› Competitive Product + Bone Marrow Aspirate +
Autograft
› Bone Marrow Aspirate + Autograft

• RESULTS - nanOss Bioactive mixed with bone Bone Marrow

marrow aspirate and Autograft had:
› Excellent handling properties Autograft Bone
› 2.5 times more new bone formation than
Competitive Product
› Statistically stronger fusions (peak load and
stiffness) than the Competitive Product
PEAK LOAD (N)

› Excellent histology results

Competitve
nanOss Bioactive Silicate Product Autograft

*nanOss Bioactive resulted in a significantly higher peak load compared to the

Competitive Product, (p<0.05), but was not different than Autograft. There was no
significant difference between the Competitive Product and Autograft.

2 NANOSS BIOACTIVE
 SYSTEM OVERVIEW

nanOss Bioactive

ORDERING INFORMATION
Unit Size Product Catalog # Storage

1cc nanOss Bioactive 90-100-01 Room Temperature

2cc nanOss Bioactive 90-100-02 Room Temperature

5cc nanOss Bioactive 90-100-05 Room Temperature

10cc nanOss Bioactive 90-100-10 Room Temperature

20cc nanOss Bioactive 90-100-20 Room Temperature

nanOss Bioactive Loaded

nanOss Bioactive Loaded

nanOss Bioactive Loaded Adapter Bone graft delivery syringe + adapter + bone graft
delivery syringe

Unit Size Product Catalog # Storage

10cc nanOss Bioactive Loaded 90-200-10 Room Temperature

nanOss Bioactive Loaded Kit (10cc unit, bone graft delivery

10cc 90-200-1002 Room Temperature
syringe & adapter)

nanOss Bioactive Loaded Accessory Kit (bone graft delivery

Each 90-900-02 Room Temperature
syringe & adapter)

Each Bone graft delivery syringe 53-syringe-1 Room Temperature

10 pack Bone graft delivery syringe 53-syringe Room Temperature

ADVANCED BONE GRAFT 3

 NANOSS BIOACTIVE | ADVANCED BONE GRAFT

INDICATIONS
NANOSS BIOACTIVE - INDICATIONS & WARNINGS

nanOss Bioactive and nanOss Bioactive Loaded are both indicated for bony voids or gaps that are not intrinsic to the stability of
bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone.
These products are indicated to be used in the posterolateral spine in conjunction with bone marrow aspirate and autograft
bone. nanOss Bioactive and nanOss Bioactive Loaded are also indicated to be gently packed into the bony voids or gaps in the
skeletal system (extremities, pelvis) in conjunction with autogenous blood and sterile saline. These products provide a bone void
filler that resorbs and is replaced with bone during the healing process.

CONTRAINDICATIONS

Use of nanOss Bioactive or nanOss Bioactive Loaded is contraindicated in the presence of one or more of the following clinical
situations:
• fractures of the epiphyseal plate.
• metabolic or systemic bone disorders that affect bone or wound healing.
• fractures for which stabilization of the fracture is not possible.
• significant vascular impairment proximal to the graft site.
• infected or contaminated wounds, or fractures for which intraoperative soft tissue coverage is not planned or possible.
• acute and chronic infections in the surgical area (soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis).
• impaired calcium metabolism.
• treatment with steroids and other drugs affecting calcium metabolism.
• immunosuppressant therapy.
• use in the area of the open epiphyseal growth plate.
• patients allergic to porcine collagen products.

WARNINGS

nanOss Bioactive and nanOss Bioactive Loaded do not possess sufficient mechanical strength to support the reduction of a
fracture site prior to soft and hard tissue in-growth or to support a load. Standard internal fixation techniques such as the use
of plates and/or screws must be followed to obtain rigid stabilization. External stabilization alone is not sufficient to achieve the
rigidity necessary for bony in-growth of nanOss Bioactive. nanOss Bioactive and nanOss Bioactive Loaded material must not
be used to gain screw purchase or to stabilize screw placement. All screws used in conjunction with this product and fixation
devices must attain rigid fixation into the host bone. nanOss Bioactive must not be used to repair metaphyseal defects.

Complete postoperative wound closure is essential. nanOss Bioactive Loaded must not be used to repair metaphyseal defects
where complete soft tissue coverage cannot be achieved.
• nanOss Bioactive Loaded must not be used to gain screw purchase or to stabilize screw placement. All screws used in con-
junction with this product and fixation devices must attain rigid fixation into the host bone.
• never introduce nanOss Bioactive Loaded into closed cavities under pressure, as this may lead to fat embolization or emboli-
zation of device into blood stream; and avoid application of nanOss Bioactive Loaded beyond intended treatment site, as this
may damage surrounding tissues. Avoid application of nanOss Bioactive Loaded beyond intended treatment site as this may
damage surrounding tissue.

Clinical human data using nanOss Bioactive is limited.

4 NANOSS BIOACTIVE
 SYSTEM OVERVIEW

PRECAUTIONS

NANOSS BIOACTIVE - INDICATIONS & WARNINGS

nanOss Bioactive and nanOss Bioactive Loaded are intended for use only by surgeons familiar with bone grafting and rigid
fixation techniques.

nanOss Bioactive and nanOss Bioactive Loaded granules are radiopaque and the radiopacity may mask underlying pathological
conditions.

nanOss Bioactive and nanOss Bioactive Loaded are intended for single use only.
• do not apply nanOss Bioactive or nanOss Bioactive Loaded dry to the defect.
• do not resterilize nanOss Bioactive or nanOss Bioactive Loaded.
• discard any un-used nanOss Bioactive or nanOss Bioactive Loaded.
• nanOss Bioactive and nanOss Bioactive Loaded have no weight bearing function. Postoperative patient management should
follow the same regimen as similar cases utilizing autogenous bone grafting. Standard postoperative practices should be
followed, particularly as applicable to defect repairs involving the use of fixation devices.
• always follow recommended mixing instructions when rehydrating nanOss Bioactive.
• postoperative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting.
Standard postoperative practices should be followed, particularly as applicable to defect repairs involving the use of fixation
devices.

REFERENCES:
† Walsh, W, Hill, R.S., Lloyd, W., Bertollo, N., Shinoda, T., Merger, A., Oliver, R., and Yu, Y. In vivo Response to Synthetic Bone Graft
Substitutes in a Preclinical Posterolateral Fusion Model. Accepted for Presentation at the 2009 North American Spine Society Meeting,
San Francisco, CA, Nov 2009.

*See product insert for complete labeling limitations related to this device.

nanOss Bioactive
is synthetic bone

ADVANCED BONE GRAFT 5

NANOSS BIOACTIVE | ADVANCED BONE GRAFT

© 2011 Pioneer Surgical Technology. All rights reserved. Pioneer Surgical Technology
The trade name Pioneer Surgical as used herein and 375 River Park Circle
elsewhere refers to the legal entity Pioneer Surgical Marquette, MI 49855
Technology, Inc. Pioneer Surgical owns the following 800-557-9909
trademarks: Pioneer, Moving Forward Together and nanOss. www.pioneersurgical.com
The following trademarks are registered in the U.S.: Pioneer.
All other trademarks are property of their respective owners
and holders.

MKT-167-D/113506 4/2011