FDA.reportPublic FDA data

Easytech Anatomical Shoulder System

Primary DI
03701037313732
Brand
Easytech Anatomical Shoulder System
Company
FX SOLUTIONS
Model
314-0042
Catalog number
314-0042
Device description
EASYTECH ANCHOR BASE TA6V Ø42 mm CEMENTLESS Ti/HA
Published
2021-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201391000Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.2021-02-16PKC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701037313732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701037313732037010373137323701037313732

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated shoulder humeral stem prosthesisA sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter42Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from light and sunlight Store away from moisture

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
263076196
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701037303740HUMELOCK REVERSEDØ36/12 CEMENTLESS LOCKABLE317-36122017-01-31
03701037303092PRCT2100-0008100-00082016-06-08
03701037303108PRCT2100-0009100-00092016-06-08
03701037303115PRCT2100-0010100-00102016-06-08
03701037303139PRCT2100-0012100-00122016-06-08
03701037303160PRCT2100-0109100-01092016-06-08
03701037303177PRCT2100-0110100-01102016-06-08
03701037303184PRCT2100-0111100-01112016-06-08
03701037303191PRCT2100-0112100-01122016-06-08
03701037303207PRCT2100-0113100-01132016-06-08
03701037305843Humelock Reversed Shoulder903-0006903-00062018-09-27
03701037305850Humelock Reversed Shoulder903-0009-01903-0009-012018-09-27
03701037305867Humelock Reversed Shoulder903-0009-02903-0009-022018-09-27
03701037305911Humelock Reversed Shoulder903-0018903-00182018-09-27
03701037305782Humelock II Cemented Shoulder System902-0334902-03342018-09-27
03701037305799Humelock II Cemented Shoulder System902-0400902-04002018-09-27
03701037305805Humelock II Cemented Shoulder System902-0500902-05002018-09-27
03701037306406Humelock II Cemented Reversible Shoulder908-0055908-00552018-09-27
03701037311776Humelock II926-10412025-08-01
03701037311783Humelock II926-10422025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556915943AETOS Shoulder SystemSmith & Nephew, Inc.PKC2026-05-18
B1132G1HB300010Shoulder Innovations Humeral Stemless SystemShoulder Innovations, Inc.PKC2026-05-04
B1132G1HB300020Shoulder Innovations Humeral Stemless SystemShoulder Innovations, Inc.PKC2026-05-04
00885556910122AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910139AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910146AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910153AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919354AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919361AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919378AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919392AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919446AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00887868580802IDENTITY HumeralZimmer, Inc.PKC2025-10-10
03701037320426EasyTech AnatomicalFX SOLUTIONSPKC2025-03-03
03701037321010FX V135FX SOLUTIONSPKC2025-02-20
03701037321027FX V135FX SOLUTIONSPKC2025-02-20
03701037321034FX V135FX SOLUTIONSPKC2025-02-20
03701037321041FX V135FX SOLUTIONSPKC2025-02-20
03701037321058FX V135FX SOLUTIONSPKC2025-02-20
03701037321065FX V135FX SOLUTIONSPKC2025-02-20
03701037321072FX V135FX SOLUTIONSPKC2025-02-20
03701037321089FX V135FX SOLUTIONSPKC2025-02-20
03701037321096FX V135FX SOLUTIONSPKC2025-02-20
03701037321102FX V135FX SOLUTIONSPKC2025-02-20
00889024678736OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678743OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678750OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678767OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678774OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678781OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18