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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fastener, fixation, biodegradable, soft tissue
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeMAI
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUITIVE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 13
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPOSITES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
DEPUY MITEK
  SUBSTANTIALLY EQUIVALENT 3
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
OSSIO , LTD.
  SUBSTANTIALLY EQUIVALENT 5
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
PARCUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SCIENCE & BIO MATERIALS (S.B.M.) SAS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL FUSION TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 2
TEKNIMED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 957 958
2021 1267 1269
2022 1425 1427
2023 1718 1720
2024 2300 2302
2025 2180 2180
2026 1600 1600

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6387 6389
Adverse Event Without Identified Device or Use Problem 707 708
Device-Device Incompatibility 486 486
Migration 406 406
Device Dislodged or Dislocated 369 369
Material Deformation 330 330
Crack 329 330
Detachment of Device or Device Component 317 317
Patient Device Interaction Problem 211 211
Difficult to Advance 205 205
Fracture 168 168
Premature Activation 126 126
Positioning Failure 119 119
Failure to Advance 102 102
Device Damaged Prior to Use 101 101
Material Twisted/Bent 81 81
Mechanical Jam 69 69
Material Separation 66 66
Physical Resistance/Sticking 65 65
Use of Device Problem 63 63
Defective Device 61 61
Insufficient Device Problem Information 59 59
Unintended Movement 56 56
Migration or Expulsion of Device 43 43
Material Split, Cut or Torn 39 39
Material Fragmentation 38 38
Appropriate Device Problem Term/Code Not Available 33 33
Device Contaminated During Manufacture or Shipping 32 32
Loose or Intermittent Connection 26 26
Damaged Thread 22 22
Delivered as Unsterile Product 22 22
Loosening of Implant Not Related to Bone-Ingrowth 21 21
Difficult to Insert 18 18
Material Frayed 18 18
Manufacturing, Packaging or Shipping Problem 17 17
Packaging Problem 17 17
Fitting Problem 16 16
Entrapment of Device 15 15
Separation Failure 12 12
Device Damaged by Another Device 12 12
Product Quality Problem 10 10
Unsealed Device Packaging 8 8
Device Damaged Prior to Receipt by User 8 8
Component Missing 7 7
Unstable 7 7
Expiration Date Error 6 6
Device Markings/Labelling Problem 6 6
Material Protrusion/Extrusion 6 6
Contamination /Decontamination Problem 6 6
Flaked 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8445 8449
Insufficient Information 766 766
Foreign Body In Patient 426 427
Unspecified Tissue Injury 421 421
No Consequences Or Impact To Patient 353 353
Unspecified Infection 246 247
Failure of Implant 210 210
Pain 115 116
Device Embedded In Tissue or Plaque 109 109
Not Applicable 100 100
Perforation 95 95
No Information 60 60
No Code Available 57 57
No Known Impact Or Consequence To Patient 54 54
Swelling/ Edema 52 53
Injury 51 51
Rupture 50 50
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 44 44
Hypersensitivity/Allergic reaction 44 45
Nerve Damage 39 39
Foreign Body Reaction 36 36
Joint Laxity 35 35
Tissue Damage 35 35
Inflammation 33 34
Loss of Range of Motion 26 26
Impaired Healing 23 23
Bacterial Infection 17 18
Post Operative Wound Infection 15 15
No Patient Involvement 15 15
Joint Dislocation 14 14
Damage to Ligament(s) 14 14
Fluid Discharge 12 12
Discomfort 12 12
Muscle/Tendon Damage 11 11
Abscess 11 12
Hemorrhage/Blood Loss/Bleeding 11 11
Adhesion(s) 10 10
Synovitis 9 9
Implant Pain 9 9
Arthropathy 9 9
Rash 9 9
Cyst(s) 8 8
Bone Fracture(s) 8 8
Sepsis 8 8
Purulent Discharge 8 8
Numbness 8 8
Necrosis 7 7
Fatigue 7 7
Reaction 7 7
Thrombosis/Thrombus 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Aju Pharm Co., Ltd. II Jan-26-2026
2 Arthrex, Inc. II Jul-21-2021
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jun-02-2023
4 Smith & Nephew, Inc. II Apr-29-2021
5 Smith & Nephew, Inc. II Oct-21-2020
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