FDA.reportPublic FDA data

Humeris Shoulder

Primary DI
03701037304570
Brand
Humeris Shoulder
Company
FX SOLUTIONS
Model
316-0017
Catalog number
316-0017
Device description
HUMERIS STEM TA6V SIZE 17 CEMENTLESS Ti/HA
Published
2017-12-14
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
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
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
03701037304570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701037304570037010373045703701037304570

GMDN Terms#

Term, Definition table
TermDefinition
Coated 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 coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without 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
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSPHX2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00811596032524F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032531F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25