FDA.reportPublic FDA data

SmartBase Core

Primary DI
00811813020297
Brand
SmartBase Core
Company
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
Model
J
Catalog number
0006-0032
Device description
The SmartBase Core is the base component of the SmartBase Assembly, which is used to set the Intelligent Reusable Instrument (IRI). The SmartBase Assembly is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) in Total Shoulder Arthroplasty (TSA).
Published
2016-09-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811813020297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811813020297008118130202978118130202970811813020297

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin holderA non-sterile cylindrical device intended to temporarily hold one or more orthopaedic pin(s) [e.g., K-wires] during sterilization and a surgical procedure for protection against damage. It is made of metal (e.g., stainless steel) and is typically a cylinder with a screw top, with lateral fenestartions to enable the penetration of sterilization fluid. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height42Millimeter
Lumen/Inner Diameter4.9Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, dark, cool place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2168005905info@customorthopaedics.com

Regulatory Flags#

DUNS number
078667390
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811813020525VisionAir 3D Stent0010-01262024-03-11
00811813020006Glenoid IRI HandleM0006-00012016-09-02
00811813020013Glenoid IRI BarrelM0006-00022016-09-02
00811813020020Glenoid IRIS Surgical TrayE0006-00112016-09-02
00811813020037Glenoid IRI CapJ0006-00032016-09-02
00811813020044Glenoid IRI Leg (10mm)L0006-0005-102016-09-02
00811813020051Glenoid IRI Leg (11mm)L0006-0005-112016-09-02
00811813020068Glenoid IRI Leg (12mm)L0006-0005-122016-09-02
00811813020075Glenoid IRI Leg (13mm)L0006-0005-132016-09-02
00811813020082Glenoid IRI Leg (14mm)L0006-0005-142016-09-02
00811813020099Glenoid IRI Leg (15mm)L0006-0005-152016-09-02
00811813020105Glenoid IRI Leg (16mm)L0006-0005-162016-09-02
00811813020112Glenoid IRI Leg (17mm)L0006-0005-172016-09-02
00811813020129Glenoid IRI Leg (18mm)L0006-0005-182016-09-02
00811813020136Glenoid IRI Leg (19mm)L0006-0005-192016-09-02
00811813020143Glenoid IRI Leg (20mm)L0006-0005-202016-09-02
00811813020150Glenoid IRI Leg (21mm)L0006-0005-212016-09-02
00811813020167Glenoid IRI Leg (22mm)L0006-0005-222016-09-02
00811813020174Glenoid IRI Leg (23mm)L0006-0005-232016-09-02
00811813020181Glenoid IRI Leg (24mm)L0006-0005-242016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
05404028001288SurgiCase PlannerMaterialise NVPHX2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-13
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13