Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device filler, bone void, calcium compound
Regulation Description Resorbable calcium salt bone void filler device.
Product CodeMQV
Regulation Number 888.3045
Device Class 2


Premarket Reviews
ManufacturerDecision
ACRO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
AUSTIN MEDICAL VENTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPOSITES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOGENNIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMENDEX OY
  SUBSTANTIALLY EQUIVALENT 1
BIOSTONE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BONALIVE BIOMATERIALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5
BONESUPPORT AB
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONVERG ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
CORLIBER (SHENZHEN) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIMENSIONAL BIOCERAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ELUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 2
GRAFTYS
  SUBSTANTIALLY EQUIVALENT 1
KUROS BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
KUROS BIOSCIENCES B.V
  SUBSTANTIALLY EQUIVALENT 9
MEDTRONIC SOFAMOR DANEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
NORAKER
  SUBSTANTIALLY EQUIVALENT 1
NOVABONE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCON, INC.
  SUBSTANTIALLY EQUIVALENT 7
ORTHOREBIRTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSDSIGN AB
  SUBSTANTIALLY EQUIVALENT 1
PROSIDYAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 2
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 4
SYNERGY BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VENTRIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
WRIGHT MEDICAL TECHNOLOGY, INC. (STRYKER CORPORATION)
  SUBSTANTIALLY EQUIVALENT 1
WRIGHTMEDICALTECHNOLOGYINC
  SUBSTANTIALLY EQUIVALENT 1
XEROTHERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 101 101
2022 47 47
2023 120 120
2024 68 68
2025 58 58
2026 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 182 182
Insufficient Information 82 82
Migration 25 25
Failure to Eject 17 17
Migration or Expulsion of Device 13 13
Break 10 10
Use of Device Problem 10 10
Fracture 9 9
No Apparent Adverse Event 9 9
Appropriate Term/Code Not Available 8 8
Patient-Device Incompatibility 8 8
Chemical Problem 8 8
Device Dislodged or Dislocated 8 8
Device Difficult to Setup or Prepare 7 7
Improper or Incorrect Procedure or Method 6 6
Patient Device Interaction Problem 6 6
Fluid/Blood Leak 4 4
Failure to Osseointegrate 4 4
Tear, Rip or Hole in Device Packaging 4 4
Biocompatibility 3 3
Activation, Positioning or Separation Problem 3 3
Off-Label Use 3 3
Nonstandard Device 3 3
Coagulation in Device or Device Ingredient 3 3
Material Integrity Problem 3 3
Osseointegration Problem 2 2
Output Problem 2 2
Contamination 2 2
Crack 2 2
Degraded 2 2
Material Too Rigid or Stiff 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Human-Device Interface Problem 1 1
Improper Chemical Reaction 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Device Damaged Prior to Use 1 1
Inaccurate Delivery 1 1
Material Separation 1 1
Unsealed Device Packaging 1 1
Difficult to Insert 1 1
Mechanical Problem 1 1
Material Discolored 1 1
Unintended Ejection 1 1
Use of Incorrect Control/Treatment Settings 1 1
Packaging Problem 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 82 82
Unspecified Infection 66 66
Insufficient Information 39 39
Pain 34 34
Hematoma 33 33
Non-union Bone Fracture 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Swelling/ Edema 26 26
Post Operative Wound Infection 26 26
Bone Fracture(s) 26 26
Unspecified Tissue Injury 17 17
Skin Discoloration 16 16
Inflammation 12 12
Wound Dehiscence 11 11
Hypersensitivity/Allergic reaction 10 10
Nerve Damage 10 10
Implant Pain 9 9
Failure of Implant 9 9
Pulmonary Embolism 7 7
Infiltration into Tissue 7 7
Arthritis 6 6
Bacterial Infection 6 6
Seroma 5 5
Thrombosis/Thrombus 5 5
Skin Infection 5 5
Foreign Body In Patient 4 4
Fluid Discharge 4 4
Joint Laxity 4 4
Ambulation Difficulties 4 4
Cyst(s) 3 3
Muscle Weakness 3 3
Fever 3 3
Malunion of Bone 3 3
Urinary Retention 3 3
Cerebrospinal Fluid Leakage 3 3
Osteolysis 3 3
Impaired Healing 3 3
Rash 2 2
Erythema 2 2
Loss of Range of Motion 2 2
Electrolyte Imbalance 2 2
Cardiac Arrest 2 2
Autoimmune Disorder 2 2
Unspecified Respiratory Problem 2 2
Embolism/Embolus 2 2
Skin Inflammation/ Irritation 2 2
Eczema 2 2
Fungal Infection 2 2
Hyperplasia 2 2
Fatigue 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Berkeley Advanced Biomaterials, LLC II Nov-18-2025
2 IsoTis OrthoBiologics, Inc. II Jan-16-2025
3 IsoTis OrthoBiologics, Inc. II Jan-15-2025
4 Medtronic Sofamor Danek USA Inc II Sep-08-2023
5 Musculoskeletal Transplant Foundation, Inc. II Feb-09-2024
6 Musculoskeletal Transplant Foundation, Inc. II Nov-17-2023
7 Musculoskeletal Transplant Foundation, Inc. II May-12-2021
8 Orthorebirth Co Ltd II May-07-2026
9 SCIENCE & BIO MATERIALS II May-02-2025
10 XTANT Medical Holdings, Inc II Apr-21-2026
-
-