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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 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 3
ACUMED, LLC
  SUBSTANTIALLY EQUIVALENT 5
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 13
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 6
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 7
CANWELL MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 6
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
FIELD ORTHOPAEDICS PTY, LTD.
  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
FUSION ORTHOPEDICS, LLC
  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 LTDA.
  SUBSTANTIALLY EQUIVALENT 6
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
HANKIL TECH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI RUIHE MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOSPITAL EQUIPMENT MANUFACTURING COMPANY
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 8
INTAI TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFE SCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAUMA S.P.A
  SUBSTANTIALLY EQUIVALENT 2
JACE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 2
KLS- MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 4
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LEITH MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAXXOS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 11
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
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NETBIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 6
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORTHO LIFE SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK , LTD.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 2
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 5
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
S.H.PITKAR ORTHOTOOLS PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDIC PTY , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 10
SKY SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 9
STRYKER LEIBINGER GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES GMBH
  SUBSTANTIALLY EQUIVALENT 2
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K191057  Park's Pectus System
  2.  K232115  TDM Large Bone Plate and Screw System
  3.  K241128  TDM Plate and Screw System
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 4
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 14
TRUEMED GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 10
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
2020 2790 2790
2021 2442 2452
2022 1700 1726
2023 2050 2079
2024 1849 1852
2025 2088 2420

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5960 6234
Break 2014 2023
Fracture 1139 1150
Device-Device Incompatibility 764 766
Migration 604 674
Insufficient Information 252 284
Material Twisted/Bent 241 243
Loosening of Implant Not Related to Bone-Ingrowth 194 194
Positioning Failure 182 182
Patient Device Interaction Problem 169 169
Material Deformation 160 160
Appropriate Term/Code Not Available 143 143
Use of Device Problem 139 139
Migration or Expulsion of Device 132 135
Device Dislodged or Dislocated 108 108
Delivered as Unsterile Product 102 103
Detachment of Device or Device Component 92 94
Tear, Rip or Hole in Device Packaging 91 92
Patient-Device Incompatibility 89 89
Defective Device 87 88
Unintended Movement 83 83
Device Slipped 80 80
Material Fragmentation 73 73
No Apparent Adverse Event 71 71
Entrapment of Device 59 60
Osseointegration Problem 56 56
Off-Label Use 55 55
Manufacturing, Packaging or Shipping Problem 42 42
Corroded 37 37
Unstable 37 37
Material Integrity Problem 35 35
Difficult to Remove 34 34
Difficult to Insert 31 31
Malposition of Device 28 28
Crack 28 28
Packaging Problem 27 27
Inadequacy of Device Shape and/or Size 26 26
Noise, Audible 26 26
Improper or Incorrect Procedure or Method 25 25
Physical Resistance/Sticking 24 25
Fitting Problem 24 24
Connection Problem 23 23
Device Contaminated During Manufacture or Shipping 23 23
Mechanical Problem 22 22
Biocompatibility 22 22
Failure to Advance 21 21
Separation Problem 20 20
Naturally Worn 19 19
Unsealed Device Packaging 19 19
Positioning Problem 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2321 2334
Non-union Bone Fracture 1643 1665
Failure of Implant 1525 1613
Pain 1521 1590
Insufficient Information 1255 1346
Unspecified Infection 919 930
No Code Available 890 890
Bone Fracture(s) 628 631
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 445 447
Post Operative Wound Infection 389 422
Injury 358 358
Loss of Range of Motion 334 335
Foreign Body In Patient 307 312
Impaired Healing 302 304
Skin Inflammation/ Irritation 288 288
Discomfort 283 285
Necrosis 249 256
Implant Pain 241 243
Malunion of Bone 235 242
No Known Impact Or Consequence To Patient 218 218
Nerve Damage 216 217
Physical Asymmetry 194 195
No Consequences Or Impact To Patient 173 173
Wound Dehiscence 169 169
Swelling/ Edema 164 165
Arthritis 160 160
Hypersensitivity/Allergic reaction 144 144
Muscle/Tendon Damage 141 144
Unspecified Tissue Injury 129 134
Device Embedded In Tissue or Plaque 89 89
Muscular Rigidity 83 83
Fall 71 71
Hemorrhage/Bleeding 64 93
Deformity/ Disfigurement 64 67
No Information 63 63
Bacterial Infection 61 61
Hematoma 58 66
Ossification 50 52
Neuropathy 50 50
Numbness 50 52
Inflammation 47 47
Joint Dislocation 43 43
No Patient Involvement 42 42
Unspecified Musculoskeletal problem 42 42
Osteopenia/ Osteoporosis 38 39
Ambulation Difficulties 38 39
Scar Tissue 35 35
Swelling 35 35
Rash 34 34
Osteolysis 34 34

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Feb-29-2024
2 Arthrex, Inc. II Apr-09-2021
3 Arthrex, Inc. II Jul-29-2020
4 Biomet II Jun-09-2020
5 Biomet, Inc. II Jan-21-2021
6 CPM Medical Consultants, LLC. II Oct-21-2025
7 Flower Orthopedics Corporation II Oct-06-2021
8 Flower Orthopedics Corporation II Aug-12-2020
9 GRAMERCY EXTREMITY ORTHOPEDICS II Apr-17-2023
10 K2M, Inc II Apr-12-2021
11 Nextremity Solutions II Feb-11-2020
12 Paragon 28, Inc. II Jul-25-2022
13 Smith & Nephew, Inc. II Feb-01-2022
14 Smith & Nephew, Inc. II Dec-10-2021
15 Smith & Nephew, Inc. II Nov-18-2021
16 Smith & Nephew, Inc. II Sep-09-2020
17 Stryker GmbH II Jan-07-2020
18 Synthes (USA) Products LLC II Mar-01-2024
19 Synthes (USA) Products LLC II Aug-17-2020
20 Synthes, Inc. II Jan-29-2020
21 Treace Medical Concepts, Inc. II Aug-23-2024
22 TriMed Inc. II Jan-31-2024
23 Tyber Medical II Feb-21-2025
24 Wishbone Medical, Inc. II Jun-04-2021
25 Wright Medical Technology Inc II Dec-17-2021
26 Wright Medical Technology, Inc. II Apr-26-2023
27 Wright Medical Technology, Inc. II Feb-24-2023
28 Wright Medical Technology, Inc. II Mar-15-2022
29 Wright Medical Technology, Inc. II Feb-25-2022
30 Wright Medical Technology, Inc. II Dec-20-2021
31 Zimmer, Inc. II Jul-28-2023
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