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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
Regulation Description Intramedullary fixation rod.
Product CodeHSB
Regulation Number 888.3020
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAPTABLE ORTHO INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 5
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CONVENTUS ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOW-FX, LLC
  SUBSTANTIALLY EQUIVALENT 2
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER
  SUBSTANTIALLY EQUIVALENT 2
FUSION ORTHOPEDICS USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 2
GM DOS REIS INDUSTRIA E COMERCIO
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS
  SUBSTANTIALLY EQUIVALENT 1
INTRAUMA S.P.A
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPÉDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 4
ORTHOPEDIATRICS CANADA ULC DBA PEGA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. (ODI-NA)
  SUBSTANTIALLY EQUIVALENT 1
ORTHOXEL DAC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
PEGA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESELUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SATORI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 7
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K231343  Redemption Duo Hindfoot Nail System
WITTENSTEIN INTENS GMBH
  SUBSTANTIALLY EQUIVALENT 1
X-BOLT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 4111 4129
2022 2733 2839
2023 2219 2240
2024 2869 2891
2025 2933 2994
2026 533 533

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5114 5228
Break 3125 3158
Device-Device Incompatibility 1953 1967
Migration 1702 1716
Fracture 1394 1409
Material Twisted/Bent 375 378
Failure to Align 274 275
Material Deformation 272 272
Migration or Expulsion of Device 259 263
Mechanical Problem 172 172
Positioning Failure 161 161
Patient Device Interaction Problem 159 160
Mechanical Jam 147 148
Malposition of Device 130 130
Detachment of Device or Device Component 114 117
Use of Device Problem 104 104
Device Dislodged or Dislocated 90 90
Physical Resistance/Sticking 89 89
Separation Problem 88 94
Failure to Advance 88 88
Corroded 86 86
Crack 86 86
No Apparent Adverse Event 73 73
Loosening of Implant Not Related to Bone-Ingrowth 71 81
Difficult to Advance 65 66
Connection Problem 62 62
Material Integrity Problem 59 59
Insufficient Information 56 64
Device Difficult to Setup or Prepare 53 53
Defective Device 53 53
Device Damaged by Another Device 52 52
Manufacturing, Packaging or Shipping Problem 49 49
Naturally Worn 47 47
Material Discolored 43 43
Contamination /Decontamination Problem 39 39
Device Slipped 39 39
Entrapment of Device 38 38
Material Fragmentation 33 33
Improper or Incorrect Procedure or Method 32 32
Appropriate Term/Code Not Available 29 29
Difficult to Remove 28 29
Loose or Intermittent Connection 25 25
Separation Failure 24 24
Deformation Due to Compressive Stress 23 23
Biocompatibility 23 23
Tear, Rip or Hole in Device Packaging 21 21
Positioning Problem 20 20
Off-Label Use 19 20
Difficult to Insert 19 19
Unintended Movement 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5243 5283
Failure of Implant 1875 1904
Insufficient Information 1718 1749
Non-union Bone Fracture 1553 1620
Limb Fracture 1345 1345
Pain 1225 1248
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 745 754
Implant Pain 576 587
Bone Fracture(s) 491 493
Unspecified Infection 345 350
Post Operative Wound Infection 324 324
Physical Asymmetry 206 210
Foreign Body In Patient 204 204
Perforation 187 187
Impaired Healing 173 176
Unspecified Tissue Injury 170 170
Necrosis 167 173
Malunion of Bone 166 166
Loss of Range of Motion 116 123
Fall 112 113
Ambulation Difficulties 111 115
Hip Fracture 98 99
Discomfort 77 78
Hematoma 69 70
Inflammation 62 64
Swelling/ Edema 60 60
Osteolysis 51 51
Wound Dehiscence 49 49
Post Traumatic Wound Infection 48 48
Hypersensitivity/Allergic reaction 46 46
Thrombosis/Thrombus 45 45
Nerve Damage 43 44
Deformity/ Disfigurement 39 40
Ossification 28 28
Hemorrhage/Bleeding 27 27
Arthritis 27 27
Joint Dislocation 26 26
Skin Inflammation/ Irritation 25 25
Device Embedded In Tissue or Plaque 25 26
Muscle/Tendon Damage 25 25
Joint Laxity 23 23
Metal Related Pathology 22 23
Pulmonary Embolism 20 20
Osteomyelitis 19 19
Osteopenia/ Osteoporosis 18 18
Unequal Limb Length 16 16
Fatigue 16 16
Bacterial Infection 14 14
Abscess 14 18
Inadequate Osseointegration 13 14

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jan-27-2023
2 Flower Orthopedics Corporation II Oct-06-2023
3 Flower Orthopedics Corporation II Jan-03-2022
4 NuVasive Specialized Orthopedics, Inc. II Nov-21-2024
5 NuVasive Specialized Orthopedics, Inc. II Dec-01-2021
6 Nuvasive Specialized Orthopedics Inc II Apr-05-2021
7 Nuvasive Specialized Orthopedics Inc II Mar-30-2021
8 Orthofix Srl II Jun-13-2025
9 Paragon 28, Inc. II Dec-02-2025
10 Paragon 28, Inc. II Mar-05-2024
11 Smith & Nephew, Inc. II May-19-2025
12 Smith & Nephew, Inc. II Aug-22-2023
13 Stryker GmbH II Jun-10-2025
14 Stryker GmbH II Jun-06-2025
15 Stryker GmbH II Jul-30-2021
16 Synthes (USA) Products LLC II Mar-01-2024
17 Synthes (USA) Products LLC II Mar-10-2023
18 Zimmer GmbH II Jun-04-2021
19 Zimmer, Inc. II Dec-22-2025
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