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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 1

MDR Year MDR Reports MDR Events
2021 1890 1891
2022 1591 1595
2023 2503 2510
2024 3779 3786
2025 3874 3880
2026 1425 1425

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5540 5544
Device-Device Incompatibility 1587 1589
Device Dislodged or Dislocated 1169 1172
Fracture 879 879
Adverse Event Without Identified Device or Use Problem 836 849
Detachment of Device or Device Component 591 591
Material Split, Cut or Torn 554 555
Premature Activation 489 489
Physical Resistance/Sticking 412 413
Difficult to Advance 363 363
Migration 351 351
Material Deformation 316 316
Positioning Failure 298 298
Failure to Advance 263 263
Material Twisted/Bent 243 244
Use of Device Problem 225 225
Material Fragmentation 194 194
Patient Device Interaction Problem 193 194
Difficult or Delayed Activation 152 152
Mechanical Jam 151 151
Crack 147 147
Defective Device 146 147
Failure to Fire 121 121
Unintended Movement 115 115
Material Frayed 92 92
Packaging Problem 91 91
Expiration Date Error 73 73
Difficult to Insert 69 70
Delivered as Unsterile Product 63 63
Fitting Problem 55 55
Separation Failure 51 51
Device Damaged Prior to Use 48 48
Appropriate Term/Code Not Available 44 44
Insufficient Information 43 44
Loosening of Implant Not Related to Bone-Ingrowth 39 39
Entrapment of Device 35 35
Device Contaminated During Manufacture or Shipping 33 33
Expulsion 31 31
Firing Problem 31 31
Material Integrity Problem 30 30
Component Missing 30 30
Unstable 26 26
Mechanical Problem 26 26
Migration or Expulsion of Device 24 24
Unsealed Device Packaging 22 22
Noise, Audible 21 21
Positioning Problem 21 22
Premature Separation 21 21
Activation, Positioning or Separation Problem 20 20
Material Rupture 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11361 11369
Insufficient Information 1429 1430
Foreign Body In Patient 931 931
Perforation 422 422
Failure of Implant 260 261
Unspecified Tissue Injury 259 259
Device Embedded In Tissue or Plaque 209 209
Pain 149 153
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
Post Operative Wound Infection 36 37
Muscle/Tendon Damage 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Scar Tissue 23 23
Bone Fracture(s) 23 23
Discomfort 18 22
Bacterial Infection 18 18
Inflammation 16 16
Thrombosis/Thrombus 14 14
Adhesion(s) 14 16
Foreign Body Reaction 13 13
Impaired Healing 12 12
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
Wound Dehiscence 9 9
Hematoma 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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