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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 5
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARCURO MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 18
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
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
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
OTS MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 3
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 8
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 7
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
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
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 3875 3882
2026 323 323

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5136 5140
Device-Device Incompatibility 1493 1495
Device Dislodged or Dislocated 1083 1086
Fracture 834 834
Adverse Event Without Identified Device or Use Problem 824 838
Detachment of Device or Device Component 548 548
Material Split, Cut or Torn 492 493
Premature Activation 424 424
Physical Resistance/Sticking 385 386
Migration 325 325
Difficult to Advance 323 323
Material Deformation 285 285
Positioning Failure 250 250
Failure to Advance 237 237
Material Twisted/Bent 217 218
Use of Device Problem 203 203
Material Fragmentation 182 182
Difficult or Delayed Activation 147 147
Crack 145 145
Patient Device Interaction Problem 145 146
Defective Device 145 146
Mechanical Jam 139 139
Unintended Movement 111 111
Failure to Fire 110 110
Packaging Problem 91 91
Material Frayed 89 89
Expiration Date Error 71 71
Difficult to Insert 65 66
Delivered as Unsterile Product 61 61
Fitting Problem 55 55
Device Damaged Prior to Use 48 48
Separation Failure 47 47
Appropriate Term/Code Not Available 44 44
Insufficient Information 41 42
Loosening of Implant Not Related to Bone-Ingrowth 35 35
Entrapment of Device 33 33
Device Contaminated During Manufacture or Shipping 31 31
Firing Problem 31 31
Expulsion 30 30
Component Missing 28 28
Material Integrity Problem 27 27
Unstable 25 25
Mechanical Problem 24 24
Migration or Expulsion of Device 23 23
Premature Separation 21 21
Noise, Audible 21 21
Unsealed Device Packaging 20 20
Positioning Problem 19 20
Activation, Positioning or Separation Problem 19 19
Activation Failure 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10515 10523
Insufficient Information 1358 1359
Foreign Body In Patient 860 860
Perforation 363 363
Unspecified Tissue Injury 257 257
Failure of Implant 248 249
Device Embedded In Tissue or Plaque 180 180
Pain 143 147
Rupture 124 124
Unspecified Infection 119 122
Loss of Range of Motion 59 60
Swelling/ Edema 51 53
Hypersensitivity/Allergic reaction 50 50
Damage to Ligament(s) 49 49
Post Operative Wound Infection 36 38
Joint Dislocation 36 38
Muscle/Tendon Damage 34 34
Joint Laxity 30 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Scar Tissue 23 23
Bone Fracture(s) 23 23
Discomfort 17 21
Inflammation 15 15
Adhesion(s) 14 16
Bacterial Infection 14 14
Thrombosis/Thrombus 14 14
Foreign Body Reaction 13 13
Synovitis 12 12
No Known Impact Or Consequence To Patient 11 11
Fever 11 11
Impaired Healing 11 11
Laceration(s) 10 10
Fibrosis 10 10
Ossification 10 10
Arthritis 10 10
Skin Inflammation/ Irritation 9 9
Hematoma 9 9
Wound Dehiscence 9 9
Fluid Discharge 8 8
No Consequences Or Impact To Patient 8 8
Muscular Rigidity 8 9
Osteolysis 8 8
Cyst(s) 7 7
Nerve Damage 7 7
Skin Discoloration 7 7
Subluxation 6 6
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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