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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device staple, fixation, bone
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeJDR
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL
  1
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX, INC.
  1
  SUBSTANTIALLY EQUIVALENT 1
ARTHROTEK, INC.
  SUBSTANTIALLY EQUIVALENT 4
AVANTA
  SUBSTANTIALLY EQUIVALENT 1
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 7
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 12
ETHICON
  2
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MITEK
  SUBSTANTIALLY EQUIVALENT 4
NEWDEAL
  SUBSTANTIALLY EQUIVALENT 4
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOHELIX SURGICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPAEDIC BIOSYSTEMS
  1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
VESITEC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS PLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 19
Failure to deploy 18
Unknown (for use when the device problem is not known) 12
No Known Device Problem 8
Deployment issue 6
Tip breakage 5
Fracture 4
Device operates differently than expected 4
No Information 4
No code available 2
Component(s), broken 2
Implant, removal of 2
Dislodged 2
Migration of device or device component 2
Device, or device fragments remain in patient 2
Suture line separation 1
Unintended ejection 1
Device Issue 1
Device inoperable 1
Failure to Adhere or Bond 1
Bent 1
Material fragmentation 1
Glass, shattered 1
Difficult to insert 1
Manufacturing or shipping issue associated with device 1
Total Device Problems 102

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 1 0 0 0 0 1 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-02-2015
2 DePuy Mitek, Inc., a Johnson & Johnson Co. II Sep-17-2008
3 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013
4 Stryker Howmedica Osteonics Corp. II Feb-23-2016

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