Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Device Code: 4608

Product Code(s): LZO

Device Classification Information

Device Type ID4608
Device NameProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Regulation DescriptionHip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type510(k)
CFR Regulation Number888.3353 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLZO
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4608
DeviceProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Product CodeLZO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis.
CFR Regulation Number888.3353 [🔎]
Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEMS, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 1
CORIN USA
 
SUBSTANTIALLY EQUIVALENT
 3
CORIN USA LIMITED
 
SUBSTANTIALLY EQUIVALENT
 3
DEPUY INTL., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
DEPUY ORTHOPAEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
DEPUY SYNTHES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
EXACTECH, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
ICONACY
 
SUBSTANTIALLY EQUIVALENT
 1
IMPLANTCAST
 
SUBSTANTIALLY EQUIVALENT
 2
KYOCERA CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
LIMACORPORATE S.P.A.
 
SUBSTANTIALLY EQUIVALENT
 6
MAXX ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDACTA INTERNATIONAL
 
SUBSTANTIALLY EQUIVALENT
 2
MEDACTA INTERNATIONAL SA
 
SUBSTANTIALLY EQUIVALENT
 8
MERETE MEDICAL GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
MICROPORT ORTHOPEDICS INC.
 
SUBSTANTIALLY EQUIVALENT
 6
MICROPORT ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
OMNI
 
SUBSTANTIALLY EQUIVALENT
 1
OMNILIFE SCIENCE
 
SUBSTANTIALLY EQUIVALENT
 3
OMNILIFE SCIENCE INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SERF
 
SUBSTANTIALLY EQUIVALENT
 2
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
TGM MEDICAL INC.
 
SUBSTANTIALLY EQUIVALENT
 1
TOTAL JOINT ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
UNITED ORTHOPEDIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 3
WALDEMAR LINK GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 3
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
Device Problems
Insufficient Information
 3204
Device Dislodged Or Dislocated
 1540
Adverse Event Without Identified Device Or Use Problem
 661
Appropriate Term/Code Not Available
 470
Fracture
 265
Break
 177
Migration Or Expulsion Of Device
161
Corroded
149
Naturally Worn
 148
Noise, Audible
 110
Material Erosion
 97
Metal Shedding Debris
 97
Unstable
 82
Loose Or Intermittent Connection
 82
Loss Of Osseointegration
 81
Difficult To Insert
 63
Malposition Of Device
59
Failure To Adhere Or Bond
 37
Material Deformation
 34
Material Disintegration
 32
Material Integrity Problem
 31
Packaging Problem
 31
Mechanical Problem
 30
Inadequacy Of Device Shape And/or Size
 29
Tear, Rip Or Hole In Device Packaging
 28
Disassembly
 27
Device Contamination With Chemical Or Other Material
 25
Positioning Problem
 25
Fitting Problem
 23
Device-Device Incompatibility
 23
Detachment Of Device Component
 19
Difficult To Position
 18
Degraded
 18
No Apparent Adverse Event
 16
Detachment Of Device Or Device Component
 15
Device Slipped
 14
Scratched Material
 14
Device Markings / Labelling Problem
 14
Loss Of Or Failure To Bond
 14
Migration
 14
Device Operates Differently Than Expected
 14
Material Discolored
 13
Osseointegration Problem
 12
Device Contaminated During Manufacture Or Shipping
 12
Biocompatibility
11
Difficult To Remove
11
Problem With Sterilization
 10
Material Fragmentation
 9
Unintended Movement
 8
Patient-Device Incompatibility
 8
Compatibility Problem
 7
Device Issue
 7
Material Separation
 7
Device Damaged Prior To Use
7
Defective Device
 7
Separation Failure
6
Misassembled
 6
Mechanical Jam
 5
Crack
 5
Separation Problem
5
Loosening Of Implant Not Related To Bone-Ingrowth
 4
Component Or Accessory Incompatibility
4
Device Damaged By Another Device
 4
Device Packaging Compromised
 4
Unsealed Device Packaging
 4
Component Missing
4
Failure To Osseointegrate
 4
Improper Or Incorrect Procedure Or Method
 3
Screw
 3
Device Abrasion From Instrument Or Another Object
 3
Retraction Problem
 3
Use Of Device Problem
 3
Off-Label Use
 3
Material Protrusion / Extrusion
 3
Difficult To Open Or Remove Packaging Material
 3
Disconnection
 3
Mechanics Altered
 3
Failure To Disconnect
 2
Manufacturing, Packaging Or Shipping Problem
 2
Device Expiration Issue
 2
Nonstandard Device
 2
Component Incompatible
 2
Positioning Failure
2
Inaccurate Information
 2
Incomplete Or Missing Packaging
 2
Sticking
 2
Ball
 2
Partial Blockage
 2
Delivered As Unsterile Product
 2
Excessive Cooling
 2
Human-Device Interface Problem
 2
Misassembled During Installation
 1
Physical Resistance
 1
Cups
 1
Defective Component
 1
Data Problem
 1
Misconnection
 1
Product Quality Problem
 1
Device Appears To Trigger Rejection
 1
Contamination During Use
 1
Total Device Problems 8242
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 II Jan-13-2016
2
Corin USA Limited
 II Apr-22-2016
3
DePuy Orthopaedics, Inc.
 II Dec-17-2014
4
Exactech, Inc.
 II Jan-17-2017
5
Exactech, Inc.
 II Jul-05-2016
6
Exactech, Inc.
 II Jul-21-2014
7
IMPLANTCAST GMBH
 II Jul-20-2018
8
Medacta Usa Inc
 II Oct-19-2018
9
MicroPort Orthopedics Inc.
 II Jan-03-2017
10
MicroPort Orthopedics Inc.
 III Dec-01-2016
11
Omnilife Science Inc.
 II Jul-14-2015
12
Omnilife Science Inc.
 II Aug-15-2014
13
Smith & Nephew, Inc.
 II Aug-29-2017
14
Waldemar Link GmbH & Co. KG (Mfg Site)
 II Jan-14-2019
15
Zimmer Biomet, Inc.
 II Apr-16-2018
16
Zimmer Biomet, Inc.
 II Mar-14-2018
17
Zimmer Biomet, Inc.
 II Dec-29-2017
18
Zimmer Biomet, Inc.
 II Mar-20-2017
19
Zimmer GmbH
 II Dec-20-2018
20
Zimmer GmbH
 II Apr-26-2018
21
Zimmer Gmbh
 II Jul-26-2016
22
Zimmer Gmbh
 II Feb-20-2015
23
Zimmer, Inc.
 II Feb-27-2015
TPLC Last Update: 2019-04-02 20:52:43
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.