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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fastener, fixation, nondegradable, soft tissue
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeMBI
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ABANZA TECNOMED S.L
  SUBSTANTIALLY EQUIVALENT 4
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AEVUMED, INC.
  SUBSTANTIALLY EQUIVALENT 6
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARCURO MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 21
ARTHROTAK, LLC
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 2
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
FIELD ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA.
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERICO LTDA.
  SUBSTANTIALLY EQUIVALENT 1
HEALTHIUM MEDTECH LIMITED
  SUBSTANTIALLY EQUIVALENT 5
INTEGRITY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JARMON MEDICAL, LLC (DBA LEGENDS ORTHOPEDICS)
  SUBSTANTIALLY EQUIVALENT 1
MARUHO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 8
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 3
ORTHO-DESIGN (PTY), LTD.
  SUBSTANTIALLY EQUIVALENT 2
ORTOBIO S.A.
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
OTS MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 3
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 9
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 4
RESPONSIVE ARTHROSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE ARTHROSCOPY, LLC
  SUBSTANTIALLY EQUIVALENT 5
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 9
SCIENCE & BIO MATERIALS (S.B.M.) SAS
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIMPARO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 6
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUTURETECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU ENDOPHIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
  SUBSTANTIALLY EQUIVALENT 2
THERAMICRO
  SUBSTANTIALLY EQUIVALENT 1
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
TRAX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1890 1891
2022 1591 1595
2023 2503 2510
2024 3779 3786
2025 3874 3880
2026 1815 1815

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5675 5679
Device-Device Incompatibility 1613 1615
Device Dislodged or Dislocated 1206 1209
Fracture 901 901
Adverse Event Without Identified Device or Use Problem 841 854
Detachment of Device or Device Component 604 604
Material Split, Cut or Torn 580 581
Premature Activation 522 522
Physical Resistance/Sticking 420 421
Difficult to Advance 380 380
Migration 369 369
Material Deformation 324 324
Positioning Failure 314 314
Failure to Advance 266 266
Material Twisted/Bent 254 255
Use of Device Problem 229 229
Material Fragmentation 197 197
Patient Device Interaction Problem 195 196
Difficult or Delayed Activation 158 158
Mechanical Jam 152 152
Crack 152 152
Defective Device 150 151
Failure to Fire 125 125
Unintended Movement 118 118
Material Frayed 97 97
Packaging Problem 91 91
Expiration Date Error 73 73
Difficult to Insert 71 72
Delivered as Unsterile Product 64 64
Fitting Problem 55 55
Separation Failure 51 51
Device Damaged Prior to Use 48 48
Appropriate Term/Code Not Available 47 47
Insufficient Information 44 45
Loosening of Implant Not Related to Bone-Ingrowth 41 41
Entrapment of Device 35 35
Material Integrity Problem 34 34
Device Contaminated During Manufacture or Shipping 33 33
Expulsion 32 32
Component Missing 32 32
Firing Problem 31 31
Unstable 27 27
Mechanical Problem 26 26
Migration or Expulsion of Device 24 24
Noise, Audible 23 23
Unsealed Device Packaging 22 22
Premature Separation 22 22
Positioning Problem 21 22
Material Rupture 20 20
Activation, Positioning or Separation Problem 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11687 11695
Insufficient Information 1444 1445
Foreign Body In Patient 959 959
Perforation 434 434
Failure of Implant 263 264
Unspecified Tissue Injury 261 261
Device Embedded In Tissue or Plaque 210 210
Pain 150 154
Unspecified Infection 128 131
Rupture 128 128
Loss of Range of Motion 61 62
Swelling/ Edema 53 55
Hypersensitivity/Allergic reaction 52 52
Damage to Ligament(s) 50 50
Joint Laxity 41 43
Joint Dislocation 39 41
Muscle/Tendon Damage 37 37
Post Operative Wound Infection 36 37
Bone Fracture(s) 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Scar Tissue 23 23
Discomfort 18 22
Bacterial Infection 18 18
Inflammation 16 16
Impaired Healing 15 15
Thrombosis/Thrombus 14 14
Adhesion(s) 14 16
Foreign Body Reaction 13 13
Synovitis 12 12
Fever 11 11
Laceration(s) 11 11
No Known Impact Or Consequence To Patient 11 11
Skin Inflammation/ Irritation 11 11
Ossification 10 10
Cyst(s) 10 10
Fibrosis 10 10
Arthritis 10 10
Hematoma 9 9
Wound Dehiscence 9 9
Fluid Discharge 8 8
No Consequences Or Impact To Patient 8 8
Osteolysis 8 8
Muscular Rigidity 8 9
Nerve Damage 8 8
Subluxation 7 7
Skin Discoloration 7 7
Non-union Bone Fracture 6 6
Erythema 6 7
Local Reaction 5 5
Implant Pain 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Oct-17-2025
2 Biomet, Inc. II Sep-23-2025
3 Paragon 28, Inc. II Sep-22-2022
4 Riverpoint Medical, LLC II Dec-08-2023
5 Smith & Nephew Inc. II Nov-29-2024
6 Stryker Corporation II Mar-12-2025
7 Stryker Corporation II Sep-28-2023
8 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
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