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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pin, fixation, threaded
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeJDW
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
AVANTA
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 6
IMMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
NEWDEAL
  SUBSTANTIALLY EQUIVALENT 2
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 6
SYNTHES
  SUBSTANTIALLY EQUIVALENT 4
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 34
Fracture 31
Implant, removal of 17
Mechanical issue 13
Device remains implanted 7
Component(s), broken 6
Unknown (for use when the device problem is not known) 6
Mechanical jam 5
Detachment of device component 5
Bent 5
Malfunction 4
Detachment of device or device component 3
Other (for use when an appropriate device code cannot be identified) 3
Material integrity issue 3
Material fragmentation 3
Entrapment of device or device component 2
Crack 2
Component missing 2
No Known Device Problem 2
Device packaging compromised 2
Fitting problem 2
Difficult to remove 2
Unintended movement 2
No Information 2
No code available 1
Sticking 1
Device markings issue 1
Device operates differently than expected 1
Incorrect device or component shipped 1
Defective component 1
Positioning Issue 1
Displacement 1
Collapse 1
Difficult to insert 1
Loose or intermittent connection 1
Device maintenance issue 1
Device, or device fragments remain in patient 1
Migration of device or device component 1
Total Device Problems 177

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 2 1 0 1 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-07-2009
2 Musculoskeletal Transplant Foundation, Inc. II Jul-24-2015
3 Orthofix Srl II Apr-28-2010
4 Smith & Nephew Inc II Jun-06-2012
5 Smith & Nephew Inc II Sep-15-2009

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