FDA.reportPublic FDA data

ORTHO SOLUTIONS SUCCESSION AFN SYSTEM

Primary DI
05055662970562
Brand
ORTHO SOLUTIONS SUCCESSION AFN SYSTEM
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS353506-NS
Catalog number
OS353506-NS
Device description
SUCCESSION IMPACTOR
Published
2025-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250622000Succession™ AFN SystemOrtho Solutions UK , Ltd.2025-08-07HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055662970562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662970562050556629705625055662970562

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4401621874378regulatory@orthosol.com

Regulatory Flags#

DUNS number
218648211
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055662922622Volition™ Plating SystemOS900091-NSOS900091-NS2026-10-16
05055662966855Volition™ Plating SystemOS720000A-NSOS720000A-NS2026-10-16
05055662966862Volition™ Plating SystemOS720000B-NSOS720000B-NS2026-10-16
05055662968538Volition™ Plating SystemOS740224-NSOS740224-NS2026-10-16
05055662969641ORTHO SOLUTIONS VOLITION PLATING SYSTEMOS720012OS720012-NS2023-10-31
05055662969474ORTHO SOLUTIONS VOLITION PLATING SYSTEMOS733114LOS733114L-NS2023-03-17
05055662976649Volition™ Plating SystemOS731052R-NSOS731052R-NS2026-10-06
05055662976656Volition™ Plating SystemOS731052L-NSOS731052L-NS2026-10-06
05055662976663Volition™ Plating SystemOS731043-NSOS731043-NS2026-10-06
05055662976670Volition™ Plating SystemOS731022R-NSOS731022R-NS2026-10-06
05055662976687Volition™ Plating SystemOS731022L-NSOS731022L-NS2026-10-06
05055662963489Volition™ Plating SystemOS731051R-NSOS731051R-NS2021-06-25
05055662963496Volition™ Plating SystemOS731051L-NSOS731051L-NS2021-06-25
05055662971057ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353017-NSOS353017-NS2025-08-15
05055662970890ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355038-SOS355038-S2026-07-10
05055662971514ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356075-SOS356075-S2026-07-10
05055662968545OrthoSolutions 'System26' Bone ScrewsOS900106-NSOS900106-NS2026-06-24
05055662971361ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353018-NSOS353018-NS2026-04-09
05055662971378ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353103-SOS353103-S2026-04-09
05055662971385ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353103L-SOS353103L-S2026-04-09

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