FDA.reportPublic FDA data

Incompass Total Ankle System

Primary DI
00889797113892
Brand
Incompass Total Ankle System
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
33851004
Catalog number
33851004
Device description
Tibial Tray
Published
2025-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797113892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797113892008897971138928897971138920889797113892

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-bearing total ankle prosthesisA sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
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
true
Expiration date on label
true
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
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797023368INVISION600022012016-09-17
00889797023375INVISION600023002016-09-17
00889797023382INVISION600023012016-09-17
00889797023436INVISION600025002016-09-17
00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862655714VantageExactech, Inc.HSN2026-03-19
10885862656834VantageExactech, Inc.HSN2026-03-10
10885862656841VantageExactech, Inc.HSN2026-03-10
10885862656858VantageExactech, Inc.HSN2026-03-10
10885862656865VantageExactech, Inc.HSN2026-03-10
10885862656872VantageExactech, Inc.HSN2026-03-10
10885862656889VantageExactech, Inc.HSN2026-03-10
10885862656896VantageExactech, Inc.HSN2026-03-10
10885862656902VantageExactech, Inc.HSN2026-03-10
10885862656919VantageExactech, Inc.HSN2026-03-10
10885862656926VantageExactech, Inc.HSN2026-03-10
10885862656933VantageExactech, Inc.HSN2026-03-10
10885862656940VantageExactech, Inc.HSN2026-03-10
00889795154026APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-02-19
00840097533681Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097533698Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097533704Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097535951Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00841731125385Hintermann Series VILEX LLCHSN2025-09-17
00841731125682Hintermann Series VILEX LLCHSN2025-09-17
00841731125736Hintermann Series VILEX LLCHSN2025-09-17
00841731125743Hintermann Series VILEX LLCHSN2025-09-17
00841731125750Hintermann Series VILEX LLCHSN2025-09-17
00841731125767Hintermann Series VILEX LLCHSN2025-09-17
00841731125989Hintermann Series VILEX LLCHSN2025-09-17
00841731125996Hintermann Series VILEX LLCHSN2025-09-17
00841731126009Hintermann Series VILEX LLCHSN2025-09-17
00841731126016Hintermann Series VILEX LLCHSN2025-09-17
00841731126023Hintermann Series VILEX LLCHSN2025-09-17
00841731126030Hintermann Series VILEX LLCHSN2025-09-17