Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

Device Code: 4464

Product Code(s): HRY

Device Classification Information

Device Type ID4464
Device NameProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Regulation DescriptionKnee Joint Femorotibial Metal/polymer Semi-constrained Cemented Prosthesis.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type510(k)
CFR Regulation Number888.3530 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHRY
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4464
DeviceProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Product CodeHRY
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionKnee Joint Femorotibial Metal/polymer Semi-constrained Cemented Prosthesis.
CFR Regulation Number888.3530 [🔎]
Premarket Reviews
ManufacturerDecision
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 1
MAKO SURGICAL CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
MAKO SURGICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
MICROPORT ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Insufficient Information
 557
Naturally Worn
 338
Loose Or Intermittent Connection
 97
Device Dislodged Or Dislocated
 95
Appropriate Term/Code Not Available
 94
Break
 85
Adverse Event Without Identified Device Or Use Problem
 69
Migration Or Expulsion Of Device
57
Unstable
 53
Fracture
 34
Loss Of Or Failure To Bond
 32
Malposition Of Device
22
Difficult To Insert
 19
Device Contaminated During Manufacture Or Shipping
 13
Fitting Problem
 10
Loss Of Osseointegration
 10
Noise, Audible
 10
Material Integrity Problem
 9
Crack
 7
Failure To Align
 7
Mechanical Problem
 6
Device Slipped
 6
Positioning Problem
 6
Scratched Material
 6
Osseointegration Problem
 6
Disassembly
 6
Contamination / Decontamination Problem
6
Device Operates Differently Than Expected
 4
Material Deformation
 4
Device Packaging Compromised
 4
Loosening Of Implant Not Related To Bone-Ingrowth
 3
Device-Device Incompatibility
 3
Material Distortion
 3
Tear, Rip Or Hole In Device Packaging
 3
Connection Problem
 3
Device Abrasion From Instrument Or Another Object
 3
Use Of Device Problem
 2
Failure To Charge
 2
Component Missing
2
Misconnection
 2
Migration
 2
Failure To Adhere Or Bond
 2
Patient-Device Incompatibility
 2
Material Erosion
 2
Flaked
 2
Device Markings / Labelling Problem
 2
Manufacturing, Packaging Or Shipping Problem
 2
Packaging Problem
 2
Unintended Movement
 2
Peeled / Delaminated
 1
Inadequacy Of Device Shape And/or Size
 1
Sticking
 1
Locking Mechanism
 1
Material Fragmentation
 1
Hole In Material
 1
Off-Label Use
 1
Material Too Rigid Or Stiff
 1
Device Issue
 1
Detachment Of Device Or Device Component
 1
Difficult To Position
 1
Labelling, Instructions For Use Or Training Problem
 1
Separation Problem
1
Device Damaged Prior To Use
1
Dull, Blunt
 1
Thermal Decomposition Of Device
 1
Moisture Or Humidity Problem
 1
Material Disintegration
 1
Expiration Date Error
 1
Material Discolored
 1
Defective Component
 1
Device Fell
 1
Compatibility Problem
 1
Degraded
 1
No Apparent Adverse Event
 1
Metal Shedding Debris
 1
Suction Problem
 1
Misassembled
 1
Delivered As Unsterile Product
 1
Total Device Problems 1745
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 II Jun-15-2015
2
DePuy Orthopaedics, Inc.
 II Mar-20-2018
3
Materialise USA LLC
 II Jan-03-2014
4
Zimmer Biomet, Inc.
 II Mar-27-2017
5
Zimmer Biomet, Inc.
 II Jan-06-2017
6
Zimmer, Inc.
 II Mar-20-2014
TPLC Last Update: 2019-04-02 20:49:48
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