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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ARC SURGICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 10
ARTHROTEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  1
  SUBSTANTIALLY EQUIVALENT 3
BIONX
  SUBSTANTIALLY EQUIVALENT 2
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
HAND INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 3
INION
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
MILTEX
  SUBSTANTIALLY EQUIVALENT 1
MITEK
  SUBSTANTIALLY EQUIVALENT 3
NEWDEAL
  SUBSTANTIALLY EQUIVALENT 2
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOHELIX SURGICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 2
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 6
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 5
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 36
No Known Device Problem 31
Fracture 13
Unknown (for use when the device problem is not known) 11
Tip breakage 10
Implant, removal of 8
No code available 6
Electro-magnetic interference (EMI) 5
Migration of device or device component 4
Device operates differently than expected 4
Use of Device Issue 3
Fitting problem 3
Other (for use when an appropriate device code cannot be identified) 3
Device remains implanted 3
Difficult to insert 3
No Information 3
Unintended movement 2
Device, or device fragments remain in patient 2
Bent 2
Product quality issue 2
Incomplete or missing packaging 2
Malfunction 2
Failure to align 1
Malposition of device 1
Device Issue 1
Device packaging compromised 1
Material integrity issue 1
Material Protrusion 1
Naturally worn 1
Improper or incorrect procedure or method 1
Implant extrusion 1
Unstable 1
Misassembled 1
Premature deployment 1
Material rupture 1
Shaft break 1
Slippage of device or device component 1
Sticking 1
Loose 1
Material fragmentation 1
Explanted 1
Component(s), broken 1
Total Device Problems 178

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

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Apr-25-2014
2 Biomet, Inc. II May-26-2016
3 MicroAire Surgical Instruments, LLC II Sep-04-2013
4 Smith & Nephew Inc II Aug-10-2010
5 Synthes USA HQ, Inc. II Sep-18-2013
6 Zimmer Inc. II Jun-26-2009

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