FDA.reportPublic FDA data

Humeris Shoulder

Primary DI
03701037303214
Brand
Humeris Shoulder
Company
FX SOLUTIONS
Model
316-0106
Catalog number
316-0106
Device description
HUMERIS STEM TA6V SIZE 06 CEMENTED
Published
2017-05-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163669000Humeris ShoulderFx Solutions2017-05-17PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701037303214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701037303214037010373032143701037303214

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
Device Size Text, specify0

Storage And Handling#

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

Regulatory Flags#

DUNS number
263076196
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701037320440FX V135 Shoulder Prosthesis906-0029906-00292026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENT906-0061906-00612026-09-22
03701037320433ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-0074951-00742026-08-17
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENT961-0017961-00172026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8803951-88032026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8806951-88062026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8809951-88092026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8812951-88122026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8815951-88152026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8818951-88182026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9803951-98032026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9806951-98062026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9809951-98092026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9812951-98122026-06-26
03701037315996ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9815951-98152026-06-26
03701037316009ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9818951-98182026-06-26
03701037316535ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9909951-99092026-06-26
03701037316542ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9912951-99122026-06-26
03701037316559ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9915951-99152026-06-26
03701037316566ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9918951-99182026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811596033460CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033477CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033484CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSKWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSPHX2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI226000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI228000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI246000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI248000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18