United States

(/us-en/index.html)

Menu

Search

Types of Bone Graft

TYPES OF BONE GRAFT BONE GRAFTING (ORAL MAXILLOFACIAL AND DENTAL)

CATEGORIES OF BONE GRAFT

Bone graft selection is critical to the outcome of any bone healing procedure. There
are currently over 200 different bone grafts available to surgeons today, each with
substantial differences in technology, materials, mechanisms of action, indications,
and clinical evidence.

Bone grafts can be categorized based on:

Composition
Mechanism of action (MOA)
Approved indication
Performance data

RECOMBINANT PROTEINS  

Recombinant proteins are naturally occurring proteins that play an active role in bone
formation and maintenance. The human sequence of these proteins can be
synthetically manufactured in a consistent, controlled process — commonly referred to
as "human recombinant" technology, or recombinant human bone morphogenetic
protein (rhBMP).

Composition: rhBMP
MOA: Highly osteoinductive and provides a strong signal for bone formation
Approval: Premarket approval (PMA) or humanitarian device exemption (HDE)
Data Required: PMAs require a pivotal human clinical trial to show safety and efficacy.

SYNTHETIC BONE GRAFT

An osteoconductor, synthetic autograft extender bulks up the supply of available
autograft bone.

Composition: Synthetically produced minerals and ceramics

MOA: Provides an osteoconductive passive scaffold for bone formation
Approval: 510(k) clearance as a bone void filler for applications not intrinsic to the stability of the bony structure
Data required: 510(k) clearance typically requires bench testing or preclinical data, usually in rabbit or sheep.

ALLOGRAFT BONE GRAFT

There are many different allograft products or forms available for use. Some allograft
tissue functions through osteoconduction and mild osteoinduction when
demineralized, and include mineralized tissue, demineralized tissue, and allograft
tissue plus cells.

These products are also regulated differently based on how they are processed. For
example, tissue based products that have a 351 HCT/Ps designation are regulated like
a medical device and require a submission to the FDA for clearance. Tissue based
products that fall into the minimally manipulated category are regulated as a 361
HCT/P and do not require a submission to the FDA.

Composition: Donor bone and tissue

Demineralized MOA: osteoconductive and osteoinductive.
351 Approval: Formulated allograft products such as DBMs have 510(k) clearance as a bone void filler for
applications not intrinsic to the stability of the bony structure.
Data required: 510(k) clearance typically requires bench testing or preclinical data, usually in a rabbit or sheep and
must perform substantially equivalent to an existing product on the market.

Composition: Donor bone and tissue

Mineralized tissue MOA: osteoconductive
Minimally manipulated Demineralized tissue MOA: osteoconductive & Osteoinductive
361 Approval. Minimally manipulated Human cellular and tissue products that meet FDA criteria for regulation
solely under 21 CFR Part 1271 regulations for 361 HCT/Ps are not regulated as medical devices, and as such do
not require 510(k) clearance.
Data required: 361 HCT/Ps require no data filing with the FDA.

XENOGRAFT

Xenograft is bone taken from an animal source and transplanted into the body. It is
treated at high temperatures (600 C to 100 C) to eliminate contamination.

Composition: bovine (cow) bone

Approval: 510(k)
MOA: Osteoconductive
KEY QUESTIONS TO ASK WHEN CATEGORIZING BONE GRAFT
FUSION MATERIAL

1. What is bone graft technology’s composition?

Mineral (synthetic)
Donor bone and tissue (allograft)
Recombinant protein (rhBMP)

2. What is the technology’s MOA?

Osteogenesis: Living cells, such as osteoblasts, that form new bone

Osteoconduction: Passive scaffold to maintain space and allow for bone formation
Osteoinduction: Active recruitment and stimulation of stem cells, which differentiate into osteoblasts and form
bone

3. How was the technology approved/cleared and for what indication?

510(k) clearance for formulated DBMs, synthetics, and biocomposites

Human cellular and tissue products (HCT/Ps) that meet FDA criteria for regulation solely under 21 CFR Part 1271
regulations for HCT/Ps are not regulated as medical devices, and as such do not require 510(k) clearance.
PMA/HDE approval for rhBMPs

4. What type of performance data are required for FDA approval/clearance?

Preclinical: Rat, rabbit, dog, sheep, or monkey data

Clinical: Human data

SEE CLINICAL AND PRE-CLINICAL EVIDENCE (/US-EN/HEALTHCARE-

PROFESSIONALS/THERAPIES-PROCEDURES/ORAL-MAXILLOFACIAL-DENTAL/BONE-
GRAFTING/CLINICAL-EVIDENCE.HTML)

   Indications, Safety, and Warnings (/us-en/healthcare-professionals/products/oral-

maxillofacial-dental/bone-grafting/indications-safety-warnings.html)

CONTACT INFORMATION

U.S. Clinician Services

800-933-2635 (tel:8009332635)

(mailto:?
body=https%3A%2F%2Fwww.medtr
onic.com%2Fus-en%2Fhealthcare-
professionals%2Ftherapies-
procedures%2Foral-maxillofacial-
 dental%2Fbone-
grafting%2Feducation-
training%2Fbone-graft-types.html)

PATIENTS AND CAREGIVERS

HEALTHCARE PROFESSIONALS

ABOUT MEDTRONIC

TRANSFORMING HEALTHCARE

(https://t
m/Medtr
witter.co
onic) tube.com
/user/Me
www.you
dtronicC
(https://
orp) edin.com
y/medtro
www.link
/compan
(https://
nic)
ebook.co
m/Medtr
www.fac
(https://
onic)

Privacy Statement(opens new window) (/us-en/privacy-statement.html)

Accessibility Statement(opens new window) (/us-en/privacy-statement/accessibility-statement.html)
Terms of Use(opens new window) (/us-en/terms-of-use.html)
Contact(opens new window) (http://www.medtronic.com/us-en/about/contact-us.html)

PMD020816-1.0

Last Updated January 2019

© 2019 Medtronic