FDA.report

Incompass Total Ankle System

Primary DI
00889797111454
Brand
Incompass Total Ankle System
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
33820064
Catalog number
33820064
Device description
Resection Height Gauge
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889797111454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797111454008897971114548897971114540889797111454

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
true

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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

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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
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