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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fastener, fixation, biodegradable, soft tissue
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeMAI
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 23
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
BIONX
  SUBSTANTIALLY EQUIVALENT 11
CONMED
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 22
ETHICON
  1
  SUBSTANTIALLY EQUIVALENT 1
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
INION
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  1
  SUBSTANTIALLY EQUIVALENT 12
MITEK
  SUBSTANTIALLY EQUIVALENT 4
SCANDIUS BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 10
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES
  SUBSTANTIALLY EQUIVALENT 2
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 182
Unknown (for use when the device problem is not known) 66
Deployment issue 37
Tip breakage 35
No Known Device Problem 20
No Information 20
No code available 13
Material fragmentation 12
Difficult to insert 5
Device, or device fragments remain in patient 5
Component(s), broken 5
Difficult to deploy 4
Use of Device Issue 4
Failure to deploy 3
Detachment of device component 3
Failure to Adhere or Bond 3
Absorption 2
Migration of device or device component 2
Suture line separation 2
Implant, removal of 2
Device operates differently than expected 2
Dislodged or dislocated 2
Material integrity issue 1
Device markings issue 1
Device Issue 1
Malfunction 1
Failure to advance 1
Tomographic pallet crack(s) 1
Nonstandard device or device component 1
Premature explantation 1
Difficult to remove 1
Slippage of device or device component 1
Component falling 1
Crack 1
Material disintegration 1
Explanted 1
Total Device Problems 443

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 1 2 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Mitek, Inc., a Johnson & Johnson Co. II Mar-06-2012
2 DePuy Mitek, Inc., a Johnson & Johnson Co. II Nov-30-2011
3 Linvatec Corp. dba ConMed Linvatec II Jul-01-2013
4 Smith & Nephew, Inc. II Sep-07-2016
5 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013

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