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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 1
ABANZA TECNOMED S.L.
  SUBSTANTIALLY EQUIVALENT 1
ABANZA TECNOMED SL.
  SUBSTANTIALLY EQUIVALENT 1
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AEVUMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANIKA THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ARCURO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 16
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 4
CONEXTIONS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DUNAMIS LLC
  SUBSTANTIALLY EQUIVALENT 1
FIELD ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
FLOWER ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERICO LTDA
  SUBSTANTIALLY EQUIVALENT 1
HEALTHIUM MEDTECH LIMITED
  SUBSTANTIALLY EQUIVALENT 5
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
JARMON MEDICAL, LLC (DBA LEGENDS ORTHOPEDICS)
  SUBSTANTIALLY EQUIVALENT 1
MARUHO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 6
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 5
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-DESIGN (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 2
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
OTS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 8
PARCUS MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 6
RESPONSIVE ARTHROSCOPY LLC
  SUBSTANTIALLY EQUIVALENT 5
RESPONSIVE ARTHROSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
RIVERPOINT MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 3
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 4
S.B.M. SAS (SCIENCE & BIO MATERIALS)
  SUBSTANTIALLY EQUIVALENT 1
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 1
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 6
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU ENDOPHIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD
  SUBSTANTIALLY EQUIVALENT 3
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
VALERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VALERIS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1453 1453
2021 1890 1890
2022 1586 1586
2023 2507 2507
2024 3770 3774
2025 1508 1508

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4559 4559
Device-Device Incompatibility 1408 1408
Device Dislodged or Dislocated 914 914
Adverse Event Without Identified Device or Use Problem 802 806
Fracture 781 781
Detachment of Device or Device Component 457 457
Material Split, Cut or Torn 335 335
Physical Resistance/Sticking 333 333
Migration 296 296
Premature Activation 275 275
Difficult to Advance 236 236
Material Deformation 222 222
Migration or Expulsion of Device 212 212
Failure to Advance 195 195
Material Separation 190 190
Positioning Failure 189 189
Material Twisted/Bent 173 173
Material Fragmentation 162 162
Mechanical Jam 152 152
Crack 135 135
Insufficient Information 132 132
Defective Device 126 126
Use of Device Problem 116 116
Unintended Movement 105 105
Patient Device Interaction Problem 94 94
Difficult or Delayed Activation 93 93
Packaging Problem 93 93
Failure to Fire 76 76
Expiration Date Error 69 69
Difficult to Insert 67 67
Material Frayed 63 63
Delivered as Unsterile Product 57 57
Fitting Problem 54 54
Appropriate Term/Code Not Available 48 48
Separation Failure 45 45
Corroded 44 44
Device Damaged Prior to Use 42 42
Firing Problem 39 39
Entrapment of Device 32 32
Expulsion 29 29
Loosening of Implant Not Related to Bone-Ingrowth 29 29
Device Contaminated During Manufacture or Shipping 27 27
Mechanical Problem 26 26
Component Missing 26 26
Difficult to Remove 22 22
Unstable 22 22
Unsealed Device Packaging 21 21
Loose or Intermittent Connection 20 20
Premature Separation 19 19
Activation, Positioning or Separation Problem 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8650 8650
Insufficient Information 1183 1183
Foreign Body In Patient 775 775
No Known Impact Or Consequence To Patient 298 298
No Information 297 297
No Consequences Or Impact To Patient 276 276
Perforation 260 260
Unspecified Tissue Injury 237 237
Failure of Implant 229 229
Device Embedded In Tissue or Plaque 153 153
Pain 144 144
Rupture 131 131
Unspecified Infection 115 115
Injury 97 97
Not Applicable 87 87
Loss of Range of Motion 61 61
Damage to Ligament(s) 50 50
Hypersensitivity/Allergic reaction 46 46
Swelling/ Edema 43 43
Joint Dislocation 35 35
Muscle/Tendon Damage 33 33
Post Operative Wound Infection 30 30
No Code Available 28 28
Osteolysis 27 27
Scar Tissue 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Joint Laxity 24 24
Bone Fracture(s) 18 18
Inflammation 14 14
Fibrosis 14 14
No Patient Involvement 14 14
Adhesion(s) 14 14
Hematoma 13 13
Foreign Body Reaction 12 12
Synovitis 12 12
Discomfort 12 16
Fever 11 11
Thrombosis/Thrombus 11 11
Wound Dehiscence 11 11
Impaired Healing 10 10
Bacterial Infection 10 10
Ossification 10 10
Muscular Rigidity 10 10
Skin Inflammation/ Irritation 9 9
Arthritis 9 9
Nerve Damage 9 9
Tissue Damage 8 8
Laceration(s) 8 8
Cyst(s) 7 7
Fluid Discharge 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 OrthoPediatrics Corp II Jul-10-2020
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 Smith & Nephew, Inc. II Jul-31-2020
7 Smith & Nephew, Inc. II Apr-22-2020
8 Smith & Nephew, Inc. II Feb-19-2020
9 Stryker Corporation II Mar-12-2025
10 Stryker Corporation II Sep-28-2023
11 Stryker Corporation II Mar-02-2020
12 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
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