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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASPINE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BACTERIN INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BIOCOMPOSITES LTD.
  SUBSTANTIALLY EQUIVALENT 9
BIOMET
  SUBSTANTIALLY EQUIVALENT 8
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 3
CYTOPHIL INC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 5
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORP.
  SUBSTANTIALLY EQUIVALENT 11
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS
  SUBSTANTIALLY EQUIVALENT 7
INION
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA
  SUBSTANTIALLY EQUIVALENT 3
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 5
ISOTIS ORTHOBIOLOGICS, INC
  SUBSTANTIALLY EQUIVALENT 4
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 15
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 9
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 9
OSSACUR AG
  SUBSTANTIALLY EQUIVALENT 3
OSTEOBIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OSTEOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 6
REGENERATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
SYNTHES
  SUBSTANTIALLY EQUIVALENT 9
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 22

Device Problems
Unknown (for use when the device problem is not known) 72
No Known Device Problem 69
Not Applicable 15
No Information 10
Break 8
Migration of device or device component 7
Device operates differently than expected 7
No code available 6
Use of Device Issue 6
Fracture 4
Device, or device fragments remain in patient 4
Device Issue 4
Failure to osseointegrate 3
Material disintegration 3
Patient-device incompatibility 2
Product quality issue 2
Incompatibility problem 2
Metal shedding debris 2
Degraded 2
Shelf life exceeded 2
Crack 2
Device expiration issue 2
Packaging issue 2
Positioning Issue 2
Difficult to insert 1
Device markings issue 1
Filling problem 1
Incorrect or inadequate result 1
Implant, removal of 1
Collapse 1
Device packaging compromised 1
Method, improper/incorrect 1
Device remains implanted 1
Material rigid or stiff 1
Leak 1
Size incorrect for patient 1
Mislabeled 1
Component missing 1
Delivered as unsterile product 1
Contamination during use 1
Improper or incorrect procedure or method 1
Total Device Problems 255

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 2 0 3 3 2 2 2 0
Class III 1 4 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AlloSource, Inc. II May-06-2014
2 Biostructures, LLC II Mar-16-2011
3 EBI, L.P. III Feb-14-2008
4 Globus Medical, Inc. II Oct-31-2013
5 Integra LifeSciences Corp II Feb-08-2012
6 Integra LifeSciences Corp II Mar-06-2009
7 Integra LifeSciences Corp. II Jun-12-2012
8 Interpore Cross International Inc III Feb-14-2008
9 LifeCell Corporation III Mar-26-2008
10 Michigan Orthopaedic Products, Inc. II Sep-17-2008
11 Musculoskeletal Transplant Foundation, Inc. II Apr-17-2015
12 Nanotherapeutics, Inc II Dec-02-2011
13 RTI Biologics, Inc. II Jun-23-2011
14 RTI Surgical, Inc. II Feb-07-2014
15 Skeletal Kinetics, Llc II Jul-24-2015
16 Surgical Tissue Network, Inc. II Jan-07-2013
17 Synthes USA II Jan-11-2012
18 Teknimed SA III Feb-22-2007
19 Theken Spine LLC II Sep-03-2009
20 Theken Spine LLC III Sep-18-2008

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