• 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 screw, fixation, bone
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeHWC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
A.M. SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 8
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 3
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIEDERMANN MEDTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
BIOMET INC
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 3
ENGINEERING CONSULTING SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED HOLDING COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
FEET FOR LIFE PODIATRY CENTER
  SUBSTANTIALLY EQUIVALENT 1
FIRST RAY LLC
  SUBSTANTIALLY EQUIVALENT 1
FLOWER ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FLOW-FX, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES
  SUBSTANTIALLY EQUIVALENT 3
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 3
FUSION ORTHOPEDICS, LLC.
  SUBSTANTIALLY EQUIVALENT 5
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICONN ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 3
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INFIX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MEMPHIS ORTHOPAEDIC DESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
MX ORTHOPEDICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPEDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 3
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 3
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 2
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OVERMED SRL.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAFETYFIX MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGN FRACTURE CARE INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMV SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
STUCKENBROCK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNCHRO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 5
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX IN TENNESSEE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 10
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Adverse Event Without Identified Device or Use Problem 5126
Break 2618
Fracture 553
Insufficient Information 449
Migration 412
Migration or Expulsion of Device 375
Unintended Movement 358
Device-Device Incompatibility 311
Material Fragmentation 293
No Apparent Adverse Event 257
Material Twisted / Bent 187
Appropriate Term/Code Not Available 141
Device Operates Differently Than Expected 136
Loose or Intermittent Connection 129
Corroded 122
Device Slipped 115
Loss of Osseointegration 108
Material Separation 97
Device Dislodged or Dislocated 85
Material Deformation 83
Difficult to Remove 77
Failure to Align 67
Bent 64
Screw 64
Fitting Problem 61
Patient-Device Incompatibility 61
Manufacturing, Packaging or Shipping Problem 54
Mechanical Problem 51
Patient Device Interaction Problem 51
Malposition of device 49
Detachment of Device or device Component 42
Crack 40
Failure To Adhere Or Bond 37
Use of Device Problem 35
Difficult to Insert 35
Mechanical Jam 33
Packaging Problem 32
Dull, Blunt 31
Difficult to Advance 31
Loosening of Implant Not Related to Bone-Ingrowth 30
Failure to Advance 30
Positioning Problem 28
Component Missing 27
Material Frayed 26
Detachment Of Device Component 26
Device Markings / Labelling Problem 24
Naturally Worn 20
Entrapment of Device 20
Separation Failure 20
Material Discolored 19
Material Split, Cut or Torn 19
Noise, Audible 18
Improper or Incorrect Procedure or Method 16
Metal Shedding Debris 16
Component Incompatible 16
Material Erosion 14
Osseointegration Problem 14
Positioning Failure 13
Biocompatibility 13
Inadequacy of Device Shape and/or Size 13
Sticking 13
Device Difficult to Maintain 12
Difficult To Position 11
Incomplete or Missing Packaging 11
Activation, Positioning or Separation Problem 11
Degraded 11
Peeled / Delaminated 11
Loss of or Failure to Bond 10
Failure to Cut 9
Material Integrity Problem 9
Tip 9
Flaked 9
Unstable 9
Defective Device 8
Device Contamination with Chemical or Other Material 7
Unknown (for use when the device problem is not known) 7
Device Handling Problem 7
Plate 7
Device Packaging Compromised 6
Component or Accessory Incompatibility 6
Failure to Osseointegrate 6
Device Damaged by Another Device 6
Delivered as Unsterile Product 5
Unsealed Device Packaging 5
Device Inoperable 5
Screw Head 5
Device Damaged Prior to Use 5
Extrusion 5
Collapse 4
Material Distortion 4
Biofilm coating in Device 4
Device Operational Issue 4
Mechanics Altered 4
Device Expiration Issue 4
Missing Value Reason 4
Retraction Problem 4
Disassembly 4
Product Quality Problem 3
Shelf Life Exceeded 3
Unraveled Material 3
Total Device Problems 13562

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Biomet, Inc. II Jul-01-2015
3 Cayenne Medical Inc. II Jul-10-2018
4 CrossRoads Extremity Systems, LLC II Oct-24-2019
5 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jun-20-2017
6 Flower Orthopedics Corporation II Mar-24-2015
7 In2Bones, SAS II Dec-09-2015
8 In2Bones, SAS II Mar-25-2015
9 In2bones USA, LLC II Aug-21-2018
10 Integra LifeSciences Corp. II Aug-19-2016
11 Integra Limited II Apr-05-2019
12 MicroAire Surgical Instruments, LLC II Jul-27-2016
13 MicroPort Orthopedics Inc. II Oct-11-2018
14 Nextremity Solutions II Jan-03-2020
15 ORTHO SOLUTIONS, LTD. II Mar-09-2018
16 Ortho Solutions Inc II Sep-16-2016
17 Ortho Solutions Inc II Oct-06-2015
18 OrthoPediatrics Corp II Sep-19-2016
19 Pega Medical Inc. II Nov-20-2015
20 Pega Medical Inc. II Jun-26-2015
21 Smith & Nephew, Inc. II Mar-20-2018
22 Smith & Nephew, Inc. II Apr-18-2017
23 Stryker Corporation II Mar-02-2018
24 Stryker Howmedica Osteonics Corp. II Apr-18-2016
25 Synthes (USA) Products LLC II Oct-24-2018
26 Synthes (USA) Products LLC II Jul-11-2016
27 Synthes (USA) Products LLC II Apr-27-2016
28 Synthes (USA) Products LLC II Nov-20-2015
29 Synthes (USA) Products LLC II Sep-18-2015
30 Synthes, Inc. II Jun-15-2015
31 Trilliant Surgical Ltd. II Jan-06-2017
32 Trilliant Surgical Ltd. II Nov-17-2016
33 Trilliant Surgical Ltd. II Aug-26-2015
34 Trilliant Surgical Ltd. II Aug-19-2015
35 Wright Medical Technology, Inc. II Nov-25-2019
36 Wright Medical Technology, Inc. II May-18-2015
37 Zimmer Biomet, Inc. II Nov-07-2019
38 Zimmer Biomet, Inc. II May-09-2019
39 Zimmer Biomet, Inc. II Sep-14-2018
40 Zimmer Biomet, Inc. II May-08-2018
41 Zimmer Biomet, Inc. II Mar-15-2018
42 Zimmer Biomet, Inc. II Feb-16-2017
43 Zimmer Biomet, Inc. II Jan-13-2016
44 Zimmer Manufacturing B.V. II May-16-2016
45 Zimmer Manufacturing B.V. II Mar-12-2016

-
-