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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
  1.  K203334  The Citrefix Knotless Suture Anchor
  2.  K210239  CITRESPLINE and CITRELOCK ACL Implants
  3.  K220833  Citregen Tendon Interference Screw, Citrelock, Cit ...
  4.  K221468  Citregen™ Tendon Interference Screw (TIS), Citrelo ...
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K203334  The Citrefix Knotless Suture Anchor
  2.  K210239  CITRESPLINE and CITRELOCK ACL Implants
  3.  K220833  Citregen Tendon Interference Screw, Citrelock, Cit ...
  4.  K221468  Citregen™ Tendon Interference Screw (TIS), Citrelo ...
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 11
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
DEPUY MITEK
  SUBSTANTIALLY EQUIVALENT 3
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
OSSIO, LTD.
  SUBSTANTIALLY EQUIVALENT 4
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 1
TEKNIMED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 957 958
2021 1267 1269
2022 1425 1427
2023 1718 1720
2024 2301 2303
2025 1951 1951

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5774 5778
Adverse Event Without Identified Device or Use Problem 704 705
Device-Device Incompatibility 479 479
Migration 344 344
Detachment of Device or Device Component 309 309
Device Dislodged or Dislocated 305 305
Crack 301 302
Material Deformation 289 289
Difficult to Advance 168 168
Premature Activation 121 121
Patient Device Interaction Problem 112 112
Fracture 104 104
Device Damaged Prior to Use 101 101
Failure to Advance 91 91
Positioning Failure 90 90
Material Twisted/Bent 82 82
Material Separation 71 71
Mechanical Jam 65 65
Defective Device 63 63
Physical Resistance/Sticking 62 62
Insufficient Information 62 62
Use of Device Problem 51 51
Unintended Movement 50 50
Appropriate Term/Code Not Available 47 47
Material Split, Cut or Torn 44 44
Material Fragmentation 44 44
Loose or Intermittent Connection 43 43
Migration or Expulsion of Device 43 43
Entrapment of Device 42 42
Difficult to Insert 30 30
Material Frayed 26 26
Device Contaminated During Manufacture or Shipping 25 25
Fitting Problem 21 21
Difficult to Remove 20 20
Delivered as Unsterile Product 19 19
Manufacturing, Packaging or Shipping Problem 18 18
Packaging Problem 16 16
Patient-Device Incompatibility 15 17
Device Damaged by Another Device 12 12
Positioning Problem 12 12
Separation Failure 11 11
Loosening of Implant Not Related to Bone-Ingrowth 10 10
Product Quality Problem 9 9
Output Problem 9 9
Unsealed Device Packaging 8 8
Mechanical Problem 7 7
Biocompatibility 6 6
Contamination /Decontamination Problem 6 6
Expiration Date Error 6 6
Device Slipped 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6905 6909
Insufficient Information 687 687
Unspecified Tissue Injury 407 407
Foreign Body In Patient 383 384
No Consequences Or Impact To Patient 353 353
Unspecified Infection 229 230
Failure of Implant 162 162
Not Applicable 100 100
Device Embedded In Tissue or Plaque 96 96
Perforation 78 78
Pain 75 76
No Information 60 60
No Code Available 57 57
No Known Impact Or Consequence To Patient 54 54
Injury 51 51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Hypersensitivity/Allergic reaction 41 42
Rupture 40 40
Swelling/ Edema 38 39
Nerve Damage 37 37
Tissue Damage 35 35
Foreign Body Reaction 32 32
Inflammation 29 30
Joint Laxity 24 24
Impaired Healing 20 20
Loss of Range of Motion 17 17
No Patient Involvement 15 15
Post Operative Wound Infection 15 15
Damage to Ligament(s) 14 14
Fluid Discharge 12 12
Abscess 11 12
Hemorrhage/Bleeding 11 11
Adhesion(s) 9 9
Synovitis 9 9
Discomfort 9 9
Implant Pain 8 8
Purulent Discharge 8 8
Sepsis 8 8
Rash 8 8
Reaction 7 7
Cyst(s) 7 7
Necrosis 7 7
Muscle/Tendon Damage 7 7
Osteolysis 6 6
Swelling 6 6
Joint Dislocation 6 6
Bone Fracture(s) 5 5
Local Reaction 5 5
Staphylococcus Aureus 5 5
Bacterial Infection 5 6

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