AUGMENT BONE GRAFT

Filler, Bone Void, Synthetic Peptide

FDA Premarket Approval P100006

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for augment® bone graft. This device is indicated for use as an alternative to autograft in arthrodesis (i. E. , surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination), due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients with preoperative or intraoperative evidence indicating the need for supplemental graft material.

DeviceAUGMENT BONE GRAFT
Classification NameFiller, Bone Void, Synthetic Peptide
Generic NameFiller, Bone Void, Synthetic Peptide
ApplicantBIOMIMETIC THERAPEUTICS,LLC
Date Received2010-02-04
Decision Date2015-09-01
Notice Date2015-10-13
PMAP100006
SupplementS
Product CodeNOX
Docket Number15M-3257
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product Yes
Applicant Address BIOMIMETIC THERAPEUTICS,LLC 389 Nichol Mill Ln franklin, TN 37067
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P100006Original Filing
S013 2021-12-15 Normal 180 Day Track No User Fee
S012 2021-09-09 Real-time Process
S011 2019-11-07 Normal 180 Day Track No User Fee
S010
S009 2019-04-11 Normal 180 Day Track
S008 2018-10-23 Normal 180 Day Track No User Fee
S007
S006 2018-07-02 Real-time Process
S005 2016-10-31 Panel Track
S004 2016-03-21 Normal 180 Day Track No User Fee
S003 2015-09-30 Normal 180 Day Track No User Fee
S002 2015-09-30 Normal 180 Day Track No User Fee
S001 2015-09-28 Real-time Process

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