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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
AVANTI ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 5
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 10
CANWELL MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHEST WALL INNOVATIONS, INC.
  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 9
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 3
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 9
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
MIKRON MAKINA SAN. VE TIC. LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NETBIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 9
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 3
ORTLER GLOBAL TIBBI GERECLER ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PACE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
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 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES GMBH
  SUBSTANTIALLY EQUIVALENT 5
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 15
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
2021 2442 2452
2022 1700 1726
2023 2049 2077
2024 1849 1852
2025 2334 2678
2026 1360 1360

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5224 5510
Break 1522 1529
Fracture 1101 1112
Device-Device Incompatibility 702 704
Migration 586 656
Patient Device Interaction Problem 295 295
Insufficient Device Problem Information 237 268
Loosening of Implant Not Related to Bone-Ingrowth 222 222
Material Twisted/Bent 212 214
Positioning Failure 168 168
Material Deformation 149 149
Use of Device Problem 141 141
Delivered as Unsterile Product 103 104
Device Dislodged or Dislocated 98 98
Migration or Expulsion of Device 95 98
Patient-Device Incompatibility 95 95
Unintended Movement 90 90
Tear, Rip or Hole in Device Packaging 86 87
Appropriate Device Problem Term/Code Not Available 82 82
Detachment of Device or Device Component 77 79
Defective Device 74 74
Device Slipped 61 61
Material Fragmentation 50 50
No Apparent Adverse Event 47 47
Off-Label Use 46 46
Osseointegration Problem 42 42
Unstable 39 39
Material Integrity Problem 38 38
Manufacturing, Packaging or Shipping Problem 36 36
Corroded 33 33
Crack 31 31
Entrapment of Device 30 31
Malposition of Device 28 28
Device Difficult to Setup or Prepare 27 27
Noise, Audible 26 26
Biocompatibility 24 24
Physical Resistance/Sticking 23 24
Failure to Advance 23 23
Device Contaminated During Manufacture or Shipping 22 22
Fitting Problem 22 22
Device Damaged by Another Device 22 23
Positioning Problem 21 21
Improper or Incorrect Procedure or Method 21 21
Packaging Problem 20 20
Difficult to Remove 19 19
Loss of Osseointegration 19 19
Unsealed Device Packaging 17 17
Naturally Worn 17 17
Dull, Blunt 16 16
Loss of or Failure to Bond 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2479 2492
Pain 1521 1590
Insufficient Information 1485 1587
Nonunion/Delayed-union Bone Fracture 1484 1506
Failure of Implant 1284 1372
Unspecified Infection 757 768
Bone Fracture(s) 494 497
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 428 430
Post Operative Wound Infection 409 442
Skin Inflammation/ Irritation 345 345
Foreign Body In Patient 319 324
Discomfort 300 302
Loss of Range of Motion 283 284
Malunion of Bone 263 270
Necrosis 241 248
Implant Pain 238 240
Physical Asymmetry 215 216
Impaired Healing 211 213
Swelling/ Edema 199 200
Nerve Damage 188 189
Wound Dehiscence 172 172
Arthritis 157 157
Muscle/Tendon Damage 157 160
Hypersensitivity/Allergic reaction 153 153
Unspecified Tissue Injury 132 137
Muscular Rigidity 90 90
Fall 65 65
Bacterial Infection 62 62
Deformity/ Disfigurement 58 61
Aseptic loosening 55 55
Numbness 52 54
Ambulation or Postural Difficulties 52 53
Hematoma 50 58
Erythema 49 49
Metal Related Pathology 48 48
Unspecified Musculoskeletal problem 48 48
Neuropathy 48 48
Device Embedded In Tissue or Plaque 48 48
Hemorrhage/Blood Loss/Bleeding 47 75
Extraskeletal ossification 44 46
Inflammation 42 42
Joint Dislocation 40 40
Foreign Body Reaction 38 38
Rash 37 37
Osteopenia/ Osteoporosis 35 36
Osteolysis 33 33
Thrombosis/Thrombus 32 32
Medical device site infection 32 34
Fluid Discharge 31 31
Fistula 30 30

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