FDA.reportPublic FDA data

INFINITY™ BIOFOAM™ 3D

Primary DI
00889797072960
Brand
INFINITY™ BIOFOAM™ 3D
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
33680072
Published
2020-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191393000INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc2019-08-22HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797072960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797072960008897970729608897970729600889797072960

GMDN Terms#

Term, Definition table
TermDefinition
Ankle prosthesis trialA copy of a final prosthesis designed to be used during ankle replacement surgery to determine the correct alignment, size, and fit of the final tibial, talar or bearing prosthesis component. It is one of a set, or a set, of graduated sizes and is typically made of synthetic polymer or metal material. This is a reusable device intended to be sterilized prior to use.

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797114820PROPHECY INCOMPASSPROPINCPROPINC2026-06-23
00889797114837PROPHECY INCOMPASSPROPINCFPROPINCF2026-06-23
00889797102353PROPHECY™ INFINITY™PROPINFFPROPINFF2022-05-25
00889797057110PROPHECY INBONEPROPINBPROPINB2016-10-27
00889797057134PROPHECY INFINITYPROPINFPROPINF2016-10-27
00840420185662PROPHECYPROPRPTPROPRPT2017-03-20
00840420194725PROPHECY INVISIONPROPINVPROPINV2018-02-14
00889797103695PROSTEP™ MICA™57790009577900092022-02-01
00889797103718PROSTEP™ MICA™57790011577900112022-02-01
00889797111089PROPHECY INCOMPASS33820300338203002026-06-23
00889797111096PROPHECY INCOMPASS33820302338203022026-06-23
00889797111102PROPHECY INCOMPASS33820303338203032026-06-23
00889797111119PROPHECY INCOMPASS33820304338203042026-06-23
00889797111126PROPHECY INCOMPASS33820305338203052026-06-23
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097514789Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514796Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514802Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514819Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514826Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514833Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514840Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514857Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514864Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514871Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514888Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514895Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514901Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514918Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097515694Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097515700Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097515717Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097533742Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097533759Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097533766Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097534046Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097536651Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097534237Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534244Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534251Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534268Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534275Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534282Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00889797111089PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111096PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23