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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 4
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 17
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 4
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 COMERCIO LTDA.
  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 5
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 3
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
RESPONSIVE ARTHROSCOPY, LLC
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 11
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
  1.  K230655  PEEK RCI Screw; Bio-Composite Screw; SignaLoc Scre ...
  2.  K242477  Shoulder Soft Tissue Anchors
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 3
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
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 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 1454 1463
2021 1890 1890
2022 1591 1591
2023 2503 2503
2024 3778 3782
2025 3219 3226

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5179 5182
Device-Device Incompatibility 1587 1587
Device Dislodged or Dislocated 1029 1029
Fracture 856 856
Adverse Event Without Identified Device or Use Problem 838 848
Detachment of Device or Device Component 548 552
Material Split, Cut or Torn 458 458
Premature Activation 386 386
Physical Resistance/Sticking 376 376
Migration 334 334
Difficult to Advance 281 281
Material Deformation 274 274
Positioning Failure 244 244
Failure to Advance 233 233
Migration or Expulsion of Device 214 214
Material Twisted/Bent 210 210
Material Separation 191 191
Material Fragmentation 190 190
Mechanical Jam 176 176
Use of Device Problem 169 169
Defective Device 145 145
Crack 144 144
Insufficient Information 137 138
Difficult or Delayed Activation 129 129
Patient Device Interaction Problem 124 124
Unintended Movement 113 113
Failure to Fire 102 102
Packaging Problem 94 94
Difficult to Insert 75 75
Expiration Date Error 74 74
Material Frayed 72 72
Delivered as Unsterile Product 62 62
Fitting Problem 55 55
Appropriate Term/Code Not Available 53 53
Device Damaged Prior to Use 50 50
Separation Failure 48 48
Corroded 44 44
Firing Problem 41 41
Entrapment of Device 35 35
Loosening of Implant Not Related to Bone-Ingrowth 31 31
Expulsion 30 30
Material Integrity Problem 30 30
Device Contaminated During Manufacture or Shipping 29 29
Component Missing 27 27
Mechanical Problem 26 26
Unstable 24 24
Difficult to Remove 22 22
Unsealed Device Packaging 21 21
Premature Separation 21 21
Loose or Intermittent Connection 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10026 10026
Insufficient Information 1313 1314
Foreign Body In Patient 889 889
Perforation 322 322
No Known Impact Or Consequence To Patient 298 305
No Information 297 297
No Consequences Or Impact To Patient 276 276
Unspecified Tissue Injury 254 254
Failure of Implant 247 247
Device Embedded In Tissue or Plaque 189 189
Pain 165 167
Rupture 131 131
Unspecified Infection 128 130
Injury 97 97
Not Applicable 87 87
Loss of Range of Motion 63 63
Damage to Ligament(s) 50 50
Hypersensitivity/Allergic reaction 50 50
Swelling/ Edema 47 49
Joint Dislocation 36 36
Muscle/Tendon Damage 34 34
Post Operative Wound Infection 33 34
No Code Available 28 28
Osteolysis 27 27
Scar Tissue 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Joint Laxity 25 27
Bone Fracture(s) 22 22
Inflammation 16 18
Discomfort 16 20
Fibrosis 14 14
No Patient Involvement 14 14
Adhesion(s) 14 14
Foreign Body Reaction 14 14
Hematoma 13 13
Synovitis 12 12
Thrombosis/Thrombus 11 11
Wound Dehiscence 11 11
Fever 11 11
Bacterial Infection 10 10
Muscular Rigidity 10 10
Impaired Healing 10 10
Ossification 10 10
Laceration(s) 9 9
Arthritis 9 9
Skin Inflammation/ Irritation 9 9
Nerve Damage 9 9
Fluid Discharge 8 8
Tissue Damage 8 8
Skin Discoloration 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Oct-17-2025
2 Biomet, Inc. II Sep-23-2025
3 Biomet, Inc. II Dec-17-2020
4 OrthoPediatrics Corp II Jul-10-2020
5 Paragon 28, Inc. II Sep-22-2022
6 Riverpoint Medical, LLC II Dec-08-2023
7 Smith & Nephew Inc. II Nov-29-2024
8 Smith & Nephew, Inc. II Jul-31-2020
9 Smith & Nephew, Inc. II Apr-22-2020
10 Smith & Nephew, Inc. II Feb-19-2020
11 Stryker Corporation II Mar-12-2025
12 Stryker Corporation II Sep-28-2023
13 Stryker Corporation II Mar-02-2020
14 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
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