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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
A PLUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 4
ACTIS MEDICAL PTY., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ACUMED, LLC
  SUBSTANTIALLY EQUIVALENT 5
ARTFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 12
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
AUXEIN MEDICAL PVT., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 4
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 8
CANWELL MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 3
DOUBLE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENDEAVOR ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
EXREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
FIXIER S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
FOOTBRIDGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FORMA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUSION INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
FUSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
GENOSTIS AF
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
GLW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA.
  SUBSTANTIALLY EQUIVALENT 7
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
HANKIL TECH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEBEI RUIHE MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOSPITAL EQUIPMENT MANUFACTURING COMPANY
  SUBSTANTIALLY EQUIVALENT 1
HYPERFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 5
INTAI TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAUMA S.P.A
  SUBSTANTIALLY EQUIVALENT 2
JACE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
JM LONGYEAR MANUFACTURING, LLC D.B.A. ABLE MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
JM LONGYEAR MANUFACTURING, LLC D/B/A ABLE MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 2
KLS MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 3
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 6
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
LEITH MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAXXOS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 8
MEDIFIELD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NETBIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 6
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOVASTEP SAS
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ORTHO LIFE SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHONOVIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDIC PTY , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 7
SKY SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 8
STRYKER LEIBINGER GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES GMBH
  SUBSTANTIALLY EQUIVALENT 4
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TECHFIT DIGITAL SURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 14
TRUEMED GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 9
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 4
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHTMEDICALTECHNOLOGYINC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2442 2452
2022 1700 1726
2023 2049 2077
2024 1849 1852
2025 2332 2676
2026 536 536

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4903 5189
Break 1634 1643
Fracture 1017 1028
Device-Device Incompatibility 656 658
Migration 566 636
Insufficient Information 233 264
Patient Device Interaction Problem 228 228
Material Twisted/Bent 209 211
Loosening of Implant Not Related to Bone-Ingrowth 207 207
Positioning Failure 145 145
Material Deformation 144 144
Use of Device Problem 134 134
Delivered as Unsterile Product 102 103
Migration or Expulsion of Device 99 102
Device Dislodged or Dislocated 96 96
Appropriate Term/Code Not Available 95 95
Tear, Rip or Hole in Device Packaging 85 86
Defective Device 77 78
Detachment of Device or Device Component 76 78
Patient-Device Incompatibility 76 76
Unintended Movement 72 72
Device Slipped 57 57
Material Fragmentation 51 51
Off-Label Use 45 45
No Apparent Adverse Event 42 42
Entrapment of Device 42 43
Osseointegration Problem 41 41
Material Integrity Problem 40 40
Unstable 38 38
Manufacturing, Packaging or Shipping Problem 37 37
Corroded 33 33
Malposition of Device 32 32
Difficult to Remove 30 30
Noise, Audible 28 28
Crack 26 26
Biocompatibility 24 24
Fitting Problem 22 22
Device Contaminated During Manufacture or Shipping 22 22
Positioning Problem 22 22
Physical Resistance/Sticking 22 23
Device Difficult to Setup or Prepare 22 22
Improper or Incorrect Procedure or Method 21 21
Failure to Advance 20 20
Packaging Problem 20 20
Unsealed Device Packaging 18 18
Mechanical Problem 17 17
Naturally Worn 17 17
Loss of or Failure to Bond 17 17
Difficult to Insert 16 16
Inaccurate Information 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2304 2317
Pain 1416 1485
Non-union Bone Fracture 1367 1389
Insufficient Information 1341 1443
Failure of Implant 1273 1361
Unspecified Infection 677 688
Bone Fracture(s) 454 457
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 427 429
Post Operative Wound Infection 387 420
Foreign Body In Patient 297 302
Skin Inflammation/ Irritation 294 294
Loss of Range of Motion 268 269
Discomfort 250 252
Malunion of Bone 242 249
Necrosis 222 229
Implant Pain 218 220
Impaired Healing 198 200
Physical Asymmetry 198 199
Swelling/ Edema 178 179
Nerve Damage 177 178
Wound Dehiscence 154 154
Muscle/Tendon Damage 148 151
Arthritis 143 143
Hypersensitivity/Allergic reaction 132 132
Unspecified Tissue Injury 127 132
Muscular Rigidity 82 82
Fall 65 65
Bacterial Infection 62 62
Deformity/ Disfigurement 56 59
Numbness 50 52
Hematoma 48 56
Hemorrhage/Bleeding 47 75
Ossification 44 46
Device Embedded In Tissue or Plaque 44 44
Unspecified Musculoskeletal problem 43 43
Neuropathy 43 43
Ambulation Difficulties 42 43
Inflammation 40 40
Osteopenia/ Osteoporosis 35 36
Joint Dislocation 33 33
Metal Related Pathology 31 31
Scar Tissue 30 30
Osteolysis 30 30
Thrombosis/Thrombus 28 28
Inadequate Osseointegration 28 28
Fever 27 27
Fluid Discharge 27 27
Foreign Body Reaction 27 27
Limb Fracture 25 25
Rash 24 24

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Feb-29-2024
2 Arthrex, Inc. II Apr-09-2021
3 Biomet, Inc. II Jan-21-2021
4 CPM Medical Consultants, LLC. II Oct-21-2025
5 Flower Orthopedics Corporation II Oct-06-2021
6 GRAMERCY EXTREMITY ORTHOPEDICS II Apr-17-2023
7 I.T.S. GmbH II Mar-20-2026
8 K2M, Inc II Apr-12-2021
9 Paragon 28, Inc. II Jul-25-2022
10 Smith & Nephew, Inc. II Feb-01-2022
11 Smith & Nephew, Inc. II Dec-10-2021
12 Smith & Nephew, Inc. II Nov-18-2021
13 Synthes (USA) Products LLC II Mar-01-2024
14 Treace Medical Concepts, Inc. II Aug-23-2024
15 TriMed Inc. II Jan-31-2024
16 Tyber Medical II Jan-20-2026
17 Tyber Medical II Feb-21-2025
18 Wishbone Medical, Inc. II Jun-04-2021
19 Wright Medical Technology Inc II Dec-17-2021
20 Wright Medical Technology, Inc. II Apr-26-2023
21 Wright Medical Technology, Inc. II Feb-24-2023
22 Wright Medical Technology, Inc. II Mar-15-2022
23 Wright Medical Technology, Inc. II Feb-25-2022
24 Wright Medical Technology, Inc. II Dec-20-2021
25 Zimmer, Inc. II Jul-28-2023
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