FDA.reportPublic FDA data

Universal Cone Impactor Head

Primary DI
00810094692292
Brand
Universal Cone Impactor Head
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
2021.57.024
Device description
Cone Impactor Head, Size 5-7, 24°
Published
2025-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094692292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094692292008100946922928100946922920810094692292

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The Klassic Knee System should be stored in a clean, dry location at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078416717
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094692803Klassic Blade Femoral Broach, Line-To-Line, size 0SRI-10054.002026-07-27
00810094692810Klassic Blade Femoral Broach, Line-To-Line, size 1SRI-10054.012026-07-27
00810094692827Klassic Blade Femoral Broach, Line-To-Line, size 2SRI-10054.022026-07-27
00810094692834Klassic Blade Femoral Broach, Line-To-Line, size 3SRI-10054.032026-07-27
00810094692841Klassic Blade Femoral Broach, Line-To-Line, size 4SRI-10054.042026-07-27
00810094692858Klassic Blade Femoral Broach, Line-To-Line, size 5SRI-10054.052026-07-27
00810094692865Klassic Blade Femoral Broach, Line-To-Line, size 6SRI-10054.062026-07-27
00810094692872Klassic Blade Femoral Broach, Line-To-Line, size 7SRI-10054.072026-07-27
00810094692889Klassic Blade Femoral Broach, Line-To-Line, size 8SRI-10054.082026-07-27
00810094692896Klassic Blade Femoral Broach, Line-To-Line, size 9SRI-10054.092026-07-27
00810094692902Klassic Blade Femoral Broach, Line-To-Line, size 10SRI-10054.102026-07-27
00810094692919Klassic Blade Femoral Broach, Line-To-Line, size 11SRI-10054.112026-07-27
00810094692926Klassic Blade Femoral Broach, Line-To-Line, size 12SRI-10054.122026-07-27
00810094692698Modular Frog Eyes2263.00.0002026-06-09
00810094692704Distal Femoral Cut Block Connector2174.00.0002026-06-09
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mm2264.00.0002026-06-09
00810094692933Magnet Spacer, 5mm2027.00.0002026-06-09
00810094692940AP Sizer with Short LegsSRI-100502026-05-15
00810094692728CR Femoral Trial, Grit BlastedSRI-10051.012026-02-05
00810094692735CR Femoral Trial, Grit BlastedSRI-10051.022026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311258185Fusion Lateral Instrument SetXtant Medical Holdings, Inc.HWA2026-10-23
04719886914771Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914801U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914818U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914825U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914832U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914849U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914856U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914863U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886915471Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886915488Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886915495Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HWA2026-10-15
00190776434694MillenniumAvalign Technologies, Inc.HWA2026-10-12
00889795151735APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWA2026-10-12
00889795151742APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWA2026-10-12
00889795151759APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWA2026-10-12
00190776433789MillenniumAvalign Technologies, Inc.HWA2026-10-08
09421028119184Enztec Partial Knee Femoral Impactor - Angled ArmENZTEC LIMITEDHWA2026-10-07
09421028119191Enztec Partial Knee Femoral Impactor with Slap Hammer - Angled ArmENZTEC LIMITEDHWA2026-10-07
00190446982623DJO SURGICALEncore Medical, L.P.HWA2026-09-30
07640187918816Ortho Development Offset Cup Impactor, 5/16-24 UNF x 3.94MPS Micro Precision Systems AGHWA2026-09-27
00190776411541MillenniumAvalign Technologies, Inc.HWA2026-08-07
03701089527934AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527941AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527958AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089528450AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089547512AMPLITUDEAMPLITUDE SASHWA2026-07-29
18257200103188ALLOGRAFT - CORTICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHWA2026-07-17
18257200103881ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
18257200103898ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17