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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 2
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 124
Unknown (for use when the device problem is not known) 66
Tip breakage 35
No Known Device Problem 19
Material fragmentation 11
No Information 9
Deployment issue 9
No code available 7
Component(s), broken 5
Device, or device fragments remain in patient 5
Failure to Adhere or Bond 3
Absorption 2
Implant, removal of 2
Difficult to insert 2
Device operates differently than expected 2
Dislodged or dislocated 2
Suture line separation 2
Material integrity issue 1
Device markings issue 1
Tomographic pallet crack(s) 1
Nonstandard device or device component 1
Premature explantation 1
Component falling 1
Crack 1
Failure to deploy 1
Material disintegration 1
Explanted 1
Device Issue 1
Malfunction 1
Failure to advance 1
Difficult to remove 1
Slippage of device or device component 1
Total Device Problems 320

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 1 2 0 0 0
Class III 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. Endoscopy Division II Sep-17-2013

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