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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rod, fixation, intramedullary and accessories
Product CodeHSB
Regulation Number 888.3020
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADAPTABLE ORTHO INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 11
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAAT MEDICAL PRODUCTS BV
  SUBSTANTIALLY EQUIVALENT 1
BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTO
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET TRAUMA
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 5
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
CONVENTUS ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
DGIMED ORTHO, INC
  SUBSTANTIALLY EQUIVALENT 3
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
EFRATGO, LTD. HI TECH BIO-SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 2
ELLIPSE TECHNOLOGIES INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 8
ELLIPSE TECHNOLOGIES, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
EMERGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EPIX ORTHOPAEDIC, CORP.
  SUBSTANTIALLY EQUIVALENT 1
FH INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
FLOW-FX, LLC
  SUBSTANTIALLY EQUIVALENT 3
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER
  SUBSTANTIALLY EQUIVALENT 2
FORCE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 2
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 2
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAFUSE LLC
  SUBSTANTIALLY EQUIVALENT 2
INTRAUMA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERETE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 4
MYLAD ORTHOPEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MYLAD ORTHOPEDIC SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
N.M.B. MEDICAL APPLICATIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
NEOORTHO PRODUTOS ORTOPEDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPÉDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NEWDEAL SAS
  SUBSTANTIALLY EQUIVALENT 1
NOVALIGN ORTHOPAEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 16
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 7
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOXEL
  SUBSTANTIALLY EQUIVALENT 2
ORTHOXEL DAC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 5
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 5
RENOVO LIFE LLC
  SUBSTANTIALLY EQUIVALENT 1
ROBERT REID INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGN FRACTURE CARE INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMALL BONE INNOVATIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
SMALL BONE INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
SONOMA ORTHOPEDIC PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SONOMA ORTHOPEDICS PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 5
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 2
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 5
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES (USA)
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES USA
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 3
VILEX IN TENNESSEE, INC
  SUBSTANTIALLY EQUIVALENT 1
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WITTENSTEIN INTENS GMBH
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 4
X-BOLT ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
X-BOLT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2014 1473 1473
2015 1671 1671
2016 1920 1920
2017 1447 1447
2018 3526 3526
2019 2517 2517
2020 3299 3299
2021 4111 4111
2022 2734 2803
2023 2232 2232
2024 2135 2135

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7599 7664
Break 5671 5671
Device-Device Incompatibility 2249 2249
Fracture 1941 1941
Migration 1940 1944
Migration or Expulsion of Device 798 798
Appropriate Term/Code Not Available 715 715
Device Operates Differently Than Expected 707 707
Insufficient Information 663 663
Failure to Align 506 506
Material Twisted/Bent 341 341
Mechanical Jam 312 312
Material Deformation 306 306
Packaging Problem 283 283
Device Contaminated During Manufacture or Shipping 275 275
Unintended Movement 266 266
Mechanical Problem 263 263
Fitting Problem 229 229
Delivered as Unsterile Product 200 200
Device Dislodged or Dislocated 182 182
Malposition of Device 172 172
Difficult to Insert 149 149
Difficult to Remove 142 142
Use of Device Problem 140 140
Connection Problem 138 138
Patient Device Interaction Problem 138 138
Detachment of Device or Device Component 128 128
Defective Device 125 125
Failure To Adhere Or Bond 108 108
Device Slipped 107 107
Corroded 105 105
Failure to Advance 103 103
Crack 103 103
No Apparent Adverse Event 103 103
Positioning Problem 101 101
Material Discolored 101 101
Improper or Incorrect Procedure or Method 97 97
Separation Problem 95 95
Loose or Intermittent Connection 87 87
Difficult to Advance 83 83
Material Integrity Problem 83 83
Material Fragmentation 83 83
Positioning Failure 82 82
Device Packaging Compromised 78 78
Sticking 68 68
Device Handling Problem 66 66
Physical Resistance/Sticking 62 62
Bent 62 62
Naturally Worn 61 61
Inadequacy of Device Shape and/or Size 59 59

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4065 4065
No Code Available 3686 3686
Failure of Implant 3453 3453
Non-union Bone Fracture 2471 2527
Pain 2431 2432
No Known Impact Or Consequence To Patient 2232 2232
Bone Fracture(s) 2121 2121
No Consequences Or Impact To Patient 1185 1185
Insufficient Information 1029 1033
No Patient Involvement 1018 1018
Limb Fracture 909 909
Unspecified Infection 882 882
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 762 762
Injury 645 645
No Information 606 606
Impaired Healing 602 603
Post Operative Wound Infection 418 418
Implant Pain 406 416
Death 298 298
Foreign Body In Patient 262 262
Hip Fracture 216 216
Necrosis 206 206
Fall 205 205
Sedation 205 205
Malunion of Bone 193 193
Discomfort 173 173
Physical Asymmetry 170 170
Device Embedded In Tissue or Plaque 169 169
Unspecified Tissue Injury 153 153
Perforation 136 136
Ambulation Difficulties 135 135
Loss of Range of Motion 104 110
Osteolysis 104 104
Hematoma 90 90
Nerve Damage 82 83
Irritation 75 75
Inflammation 72 72
Tissue Damage 68 68
Ossification 60 60
Not Applicable 58 58
Arthritis 54 54
Reaction 54 54
Wound Dehiscence 49 49
Deformity/ Disfigurement 49 50
Swelling/ Edema 47 47
Hypersensitivity/Allergic reaction 44 44
Joint Dislocation 40 40
Bacterial Infection 36 36
Thrombosis/Thrombus 36 36
Osteopenia/ Osteoporosis 32 32

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Apr-02-2012
2 Acumed LLC II May-10-2010
3 Advanced Orthopaedic Solutions Inc II Mar-22-2010
4 Biomet, Inc. II Jan-27-2023
5 Biomet, Inc. II Dec-17-2020
6 Biomet, Inc. II May-26-2016
7 Biomet, Inc. II Apr-30-2012
8 CarboFix Orthopedics, Ltd. II Jun-14-2016
9 EBI, L.P. III Sep-22-2009
10 EBI, L.P. III Sep-21-2009
11 Flower Orthopedics Corporation II Oct-06-2023
12 Flower Orthopedics Corporation II Jan-03-2022
13 Integra LifeSciences Corp. II Mar-23-2017
14 Integra LifeSciences Corp. II Apr-16-2012
15 Integra LifeSciences Corporation II Jul-16-2013
16 Integra LifeSciences Corporation II Nov-02-2010
17 Medacta Usa II Nov-12-2014
18 Merete Medical GmbH II Nov-06-2020
19 NuVasive Specialized Orthopedics, Inc. II Dec-01-2021
20 Nuvasive Specialized Orthopedics Inc II Apr-05-2021
21 Nuvasive Specialized Orthopedics Inc II Mar-30-2021
22 Nuvasive Specialized Orthopedics Inc II Oct-07-2020
23 Ortho Solutions Inc II Jul-28-2017
24 OrthoPediatrics Corp II Oct-25-2019
25 OrthoPediatrics Corp II Oct-13-2019
26 OrthoPediatrics Corp III Dec-22-2016
27 OrthoPediatrics Corp II Nov-05-2012
28 Orthofix, Inc II Feb-28-2013
29 Orthofix, Inc II Nov-13-2009
30 Orthopediatrics Corp II May-12-2010
31 Paragon 28, Inc. II Mar-05-2024
32 Pega Medical Inc. II Aug-14-2019
33 Pega Medical Inc. II Apr-29-2015
34 Pega Medical Inc. II Apr-02-2015
35 Pega Medical Inc. II Apr-18-2014
36 Pega Medical Inc. II Apr-10-2014
37 Pega Medical Inc. II Mar-02-2011
38 Smith & Nephew Inc II Apr-17-2013
39 Smith & Nephew, Inc. II Aug-22-2023
40 Stryker GmbH II Jul-30-2021
41 Stryker GmbH II Jun-16-2020
42 Stryker GmbH II Aug-22-2018
43 Stryker GmbH II Jul-10-2018
44 Stryker Howmedica Osteonics Corp. II Sep-13-2016
45 Stryker Howmedica Osteonics Corp. II Feb-25-2016
46 Stryker Howmedica Osteonics Corp. II Oct-14-2014
47 Stryker Howmedica Osteonics Corp. II Jan-28-2014
48 Stryker Howmedica Osteonics Corp. II Jul-31-2013
49 Stryker Howmedica Osteonics Corp. II Jul-16-2012
50 Stryker Howmedica Osteonics Corp. II Nov-09-2010
51 Stryker Howmedica Osteonics Corp. II Sep-02-2010
52 Stryker Howmedica Osteonics Corp. II Feb-24-2010
53 Stryker Howmedica Osteonics Corp. III Aug-18-2009
54 Stryker Spine II Nov-08-2011
55 Synthes (USA) Products LLC II Mar-01-2024
56 Synthes (USA) Products LLC II Mar-10-2023
57 Synthes (USA) Products LLC II Feb-13-2018
58 Synthes (USA) Products LLC II Nov-19-2016
59 Synthes (USA) Products LLC II Dec-04-2015
60 Synthes (USA) Products LLC II Oct-15-2015
61 Synthes (USA) Products LLC II Jul-16-2015
62 Synthes USA HQ, Inc. II Dec-10-2013
63 Synthes USA HQ, Inc. II Dec-05-2013
64 Synthes USA HQ, Inc. II Nov-25-2013
65 Synthes USA HQ, Inc. II Nov-20-2013
66 Synthes USA HQ, Inc. II Aug-26-2013
67 Synthes USA HQ, Inc. II Jul-23-2012
68 Synthes, Inc. II Jun-26-2015
69 Synthes, Inc. II May-12-2015
70 Synthes, Inc. II Mar-30-2015
71 Synthes, Inc. II Nov-14-2014
72 Tornier, Inc II Jul-29-2015
73 Vilex In Tennessee Inc II Jun-08-2015
74 Wright Medical Technology Inc II May-02-2012
75 Wright Medical Technology, Inc. II Nov-25-2019
76 Wright Medical Technology, Inc. II Apr-13-2018
77 Zimmer Biomet, Inc. II Nov-07-2019
78 Zimmer Biomet, Inc. II Nov-14-2018
79 Zimmer Biomet, Inc. II Oct-18-2018
80 Zimmer Biomet, Inc. II Sep-25-2018
81 Zimmer Biomet, Inc. II Sep-13-2018
82 Zimmer Biomet, Inc. II Apr-25-2018
83 Zimmer Biomet, Inc. II Apr-20-2018
84 Zimmer Biomet, Inc. II Mar-27-2018
85 Zimmer Biomet, Inc. II Mar-14-2018
86 Zimmer Biomet, Inc. II Mar-14-2018
87 Zimmer Biomet, Inc. II Jan-29-2018
88 Zimmer Biomet, Inc. II Jun-15-2017
89 Zimmer Biomet, Inc. II Jun-01-2017
90 Zimmer Biomet, Inc. II Mar-20-2017
91 Zimmer GmbH II Jun-04-2021
92 Zimmer Gmbh II Oct-14-2015
93 Zimmer Inc. II Dec-28-2010
94 Zimmer Inc. II Nov-24-2009
95 Zimmer Inc. II Aug-04-2009
96 Zimmer Inc. II May-18-2009
97 Zimmer Manufacturing B.V. II May-16-2016
98 Zimmer Manufacturing B.V. II Mar-12-2016
99 Zimmer, Inc. II Jul-13-2015
100 Zimmer, Inc. II Feb-20-2014
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