• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device plate, fixation, bone
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeHRS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 19
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 19
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
AVANTA
  SUBSTANTIALLY EQUIVALENT 3
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 39
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 22
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 6
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HAND INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 6
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 3
INION
  SUBSTANTIALLY EQUIVALENT 3
INTEGRA
  SUBSTANTIALLY EQUIVALENT 4
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 8
KOROS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 3
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 2
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MONDEAL MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 3
NEWDEAL
  SUBSTANTIALLY EQUIVALENT 9
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  14
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 4
ORTHOHELIX SURGICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 17
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 11
PFIZER
  SUBSTANTIALLY EQUIVALENT 3
PIONEER
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 24
SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
SPINAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  1
  SUBSTANTIALLY EQUIVALENT 46
SYNTHES
  1
  SUBSTANTIALLY EQUIVALENT 96
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 6
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 38
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 29

Device Problems
No Known Device Problem 994
Break 982
Fracture 250
No Information 180
Implant, removal of 155
Migration of device or device component 143
Device operates differently than expected 118
Unknown (for use when the device problem is not known) 116
Fitting problem 97
No code available 73
Component(s), broken 69
Material fragmentation 59
Unintended movement 51
Difficult to insert 41
Bent 41
Explanted 38
Loose or intermittent connection 37
Difficult to remove 30
Dislodged or dislocated 28
Slippage of device or device component 26
Dull 24
Malfunction 24
Malposition of device 24
Device markings issue 23
Other (for use when an appropriate device code cannot be identified) 21
Material deformation 20
Detachment of device or device component 18
Metal shedding debris 17
Failure to Adhere or Bond 17
Electro-magnetic interference (EMI) 16
Component missing 16
Device-device incompatibility 15
Positioning Issue 15
Not Applicable 14
Failure to align 14
Device Issue 13
Device remains implanted 13
Mechanical issue 13
Corrosion 12
Detachment of device component 12
Failure to osseointegrate 12
Loss of osseointegration 9
Use of Device Issue 9
Connection issue 9
Patient-device incompatibility 8
Mechanical jam 8
Packaging issue 8
Device inoperable 8
Loose 8
Material integrity issue 7
Mechanics altered 7
Foreign material present in device 7
Material separation 6
Sticking 5
Material rupture 5
Improper or incorrect procedure or method 5
Material discolored 5
Disengaged 4
Crack 4
Size incorrect for patient 4
Naturally worn 4
Device or device component damaged by another device 4
Component or accessory incompatibility 4
Device or device fragments location unknown 4
Failure to separate 4
Defective item 3
Locking mechanism failure 3
Incompatibility problem 3
Material Distortion 3
Device handling issue 3
Unraveled material 3
Tip breakage 3
Replace 3
Device, or device fragments remain in patient 3
Component falling 3
Disassembly 3
Incorrect measurement 3
Peeled 3
Difficult to position 2
Delivered as unsterile product 2
Misassembled 2
Device expiration issue 2
Displacement 2
Degraded 2
User used incorrect product for intended use 2
Unsealed device packaging 2
Unstable 2
Internal fixation, revision of 2
Implant, repositioning of 2
Manufacturing or shipping issue associated with device 2
Osseointegration issue 2
Difficult to advance 2
Extrusion 2
Device, removal of (non-implant) 2
Defective component 2
Failure to cut 1
Failure to advance 1
Split 1
Structural problem 1
Implant breakage or physical damage 1
Total Device Problems 4105

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 2 3 5 5 5 9 9 10 12 8 1
Class III 1 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ACUTE Innovations, LLC II Jan-28-2014
2 Acumed LLC II Apr-25-2014
3 Acumed LLC II Jun-16-2010
4 Acumed LLC III Aug-28-2008
5 Acute Innovations Llc II Dec-01-2011
6 Arthrex, Inc. II Apr-08-2016
7 Biomet Microfixation, Inc. II Jan-24-2012
8 Biomet Microfixation, Inc. II May-27-2009
9 Biomet, Inc. II May-26-2016
10 Biomet, Inc. II Dec-18-2015
11 Biomet, Inc. II Jul-10-2015
12 Biomet, Inc. II Jul-08-2015
13 Biomet, Inc. II Aug-13-2014
14 Biomet, Inc. II Jan-10-2014
15 Biomet, Inc. II Apr-19-2012
16 Depuy Orthopaedics, Inc. II Mar-07-2011
17 Depuy Orthopaedics, Inc. II Feb-11-2009
18 In2Bones, SAS II Jan-06-2017
19 Integra LifeSciences Corp II Dec-01-2008
20 Integra LifeSciences Corp. II Jun-14-2016
21 Integra LifeSciences Corp. II Aug-01-2012
22 Integra LifeSciences Corp. II Mar-02-2012
23 Integra LifeSciences Corp. II Jan-25-2011
24 OrthoHelix Surgical Designs Inc II Dec-19-2007
25 OrthoHelix Surgical Designs Inc III Jan-19-2007
26 OrthoPediatrics Corp II Sep-18-2015
27 OrthoPediatrics Corp II Nov-14-2013
28 OrthoPediatrics Corp II Nov-22-2012
29 OrthoPediatrics Corp II Jul-20-2012
30 Orthohelix Surgical Designs Inc II Jan-11-2012
31 Orthohelix Surgical Designs Inc II Aug-29-2011
32 Smith & Nephew Inc II Aug-31-2010
33 Smith & Nephew, Inc. II Dec-04-2015
34 Stryker Howmedica Osteonics Corp. II Feb-16-2011
35 Stryker Howmedica Osteonics Corp. II Apr-13-2009
36 Stryker Howmedica Osteonics Corp. II Mar-25-2008
37 Synthes II Jan-11-2007
38 Synthes (USA) Products LLC II Aug-11-2016
39 Synthes (USA) Products LLC II Jun-10-2016
40 Synthes (USA) Products LLC II Nov-06-2015
41 Synthes (USA) Products LLC II Oct-30-2015
42 Synthes (USA) Products LLC II Oct-15-2015
43 Synthes (USA) Products LLC II Nov-27-2013
44 Synthes (USA) Products LLC II Aug-26-2013
45 Synthes Spine II Jun-01-2009
46 Synthes Spine II May-21-2009
47 Synthes USA (HQ), Inc. II Nov-02-2010
48 Synthes USA (HQ), Inc. II Feb-24-2010
49 Synthes USA HQ, Inc. II Nov-22-2013
50 Synthes USA HQ, Inc. II Aug-26-2013
51 Synthes USA HQ, Inc. II Jun-19-2013
52 Synthes USA HQ, Inc. II Mar-15-2013
53 Synthes, Inc. II Mar-25-2014
54 Synthes, Inc. II Mar-11-2014
55 Trilliant Surgical Ltd. II Sep-04-2015
56 Trilliant Surgical Ltd. II Aug-31-2015
57 Trimed Inc II Sep-20-2016
58 Wright Medical Technology Inc II Aug-09-2010
59 Wright Medical Technology, Inc. II Sep-01-2015
60 Wright Medical Technology, Inc. II Apr-22-2015
61 Wright Medical Technology, Inc. II Sep-08-2014
62 Zimmer Biomet, Inc. II Jan-14-2016
63 Zimmer Inc. II Sep-11-2008
64 Zimmer Manufacturing B.V. II Mar-12-2016
65 Zimmer, Inc. II Aug-26-2014
66 Zimmer, Inc. II Jul-30-2014
67 Zimmer, Inc. II Feb-20-2014
68 Zimmer, Inc. II Dec-27-2013
69 Zimmer, Inc. II Aug-27-2013
70 Zimmer, Inc. II Nov-06-2012
71 Zimmer, Inc. II Aug-10-2012

-
-