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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 2
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 12
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
AUXEIN MEDICAL PVT. LTD
  SUBSTANTIALLY EQUIVALENT 1
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 4
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 6
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 1
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 1
FUSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
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 LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAUMA S.P.A
  SUBSTANTIALLY EQUIVALENT 1
JACE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
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 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 3
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LEITH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 11
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 2
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 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 3
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
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 1
TDM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TECHFIT DIGITAL SURGERY INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 9
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
TYBER MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 4
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 3
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2790 2790
2021 2443 2443
2022 1700 1703
2023 2058 2058
2024 1866 1868
2025 743 958

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5335 5500
Break 1876 1878
Fracture 1009 1011
Device-Device Incompatibility 673 673
Migration 522 576
Insufficient Information 241 241
Material Twisted/Bent 209 209
Loosening of Implant Not Related to Bone-Ingrowth 156 156
Positioning Failure 147 147
Appropriate Term/Code Not Available 141 141
Material Deformation 140 140
Patient Device Interaction Problem 137 137
Migration or Expulsion of Device 132 132
Use of Device Problem 111 111
Device Dislodged or Dislocated 102 102
Delivered as Unsterile Product 99 99
Tear, Rip or Hole in Device Packaging 88 88
Device Slipped 78 78
Unintended Movement 78 78
Detachment of Device or Device Component 76 76
No Apparent Adverse Event 75 75
Patient-Device Incompatibility 75 75
Material Fragmentation 69 69
Defective Device 61 61
Entrapment of Device 57 57
Off-Label Use 52 52
Osseointegration Problem 48 48
Manufacturing, Packaging or Shipping Problem 42 42
Difficult to Remove 34 34
Material Integrity Problem 32 32
Difficult to Insert 31 31
Corroded 29 29
Unstable 27 27
Packaging Problem 27 27
Inadequacy of Device Shape and/or Size 26 26
Crack 25 25
Malposition of Device 25 25
Fitting Problem 24 24
Connection Problem 23 23
Physical Resistance/Sticking 23 23
Improper or Incorrect Procedure or Method 23 23
Mechanical Problem 22 22
Naturally Worn 20 20
Unsealed Device Packaging 19 19
Separation Problem 19 19
Device Contaminated During Manufacture or Shipping 19 19
Loss of or Failure to Bond 17 17
Inaccurate Information 16 16
Loose or Intermittent Connection 16 16
Noise, Audible 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2073 2073
Non-union Bone Fracture 1526 1527
Failure of Implant 1443 1499
Pain 1380 1429
Insufficient Information 1052 1073
No Code Available 890 890
Unspecified Infection 835 836
Bone Fracture(s) 589 590
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 440 441
Injury 358 358
Post Operative Wound Infection 348 372
Loss of Range of Motion 305 305
Impaired Healing 286 286
Foreign Body In Patient 270 270
Skin Inflammation/ Irritation 253 253
Discomfort 252 252
Necrosis 237 237
Implant Pain 228 228
No Known Impact Or Consequence To Patient 218 218
Nerve Damage 207 207
Malunion of Bone 206 206
Physical Asymmetry 187 187
No Consequences Or Impact To Patient 173 173
Wound Dehiscence 152 152
Swelling/ Edema 147 147
Arthritis 138 138
Unspecified Tissue Injury 128 128
Hypersensitivity/Allergic reaction 122 122
Muscle/Tendon Damage 87 87
Device Embedded In Tissue or Plaque 82 82
Muscular Rigidity 77 77
Fall 64 64
No Information 63 63
Deformity/ Disfigurement 62 64
Hematoma 50 58
Inflammation 45 45
Ossification 43 45
Numbness 43 43
Unspecified Musculoskeletal problem 42 42
No Patient Involvement 42 42
Hemorrhage/Bleeding 42 67
Joint Dislocation 42 42
Ambulation Difficulties 37 37
Osteopenia/ Osteoporosis 37 37
Swelling 35 35
Bacterial Infection 35 35
Skin Irritation 34 34
Scar Tissue 34 34
Adhesion(s) 32 32
Osteolysis 31 31

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