FDA.reportPublic FDA data

QUANTUM

Primary DI
03701337606329
Brand
QUANTUM
Company
IN2BONES
Model
M50 SC175
Catalog number
M50 SC175
Device description
QUANTUM TALAR IMPLANT WITH KEEL RIGHT SIZE 5
Published
2024-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191380000Quantum® Total Ankle ProsthesisIn2bones Sas2020-01-29HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701337606329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701337606329037013376063293701337606329

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
263616749
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701337614355QUANTUMM05 PSIM05 PSI2024-12-13
03760225715499Kirschner wireK20 NS150K20 NS1502016-03-18
03760225710968IBS™G01 00852G01 008522020-06-11
03760225710975NEOFUSEG01 00862G01 008622020-06-11
03760225711002NEOFUSEG01 00891G01 008912020-06-11
03760225713129IBS™G01 00411G01 004112020-06-11
03760225714263IBS™G01 00421G01 004212020-06-11
03760225717004NEOFUSEP02 00081P02 000812019-07-17
03760225717011NEOFUSEP02 00071P02 000712019-07-17
03760225717110NEOFUSEP02 00171P02 001712019-07-17
03760225717172NEOFUSEP02 00011P02 000112019-07-17
03760225717189NEOFUSEP02 00021P02 000212019-07-17
03760225717219NEOFUSEP02 00051P02 000512019-07-17
03701337606800NEOFUSEP02 00301P02 003012022-05-10
03760225713167IBS™G01 01271G01 012712022-05-09
03760225713174IBS™G01 01261G01 012612022-05-09
03760225713181IBS™G01 01251G01 012512022-05-09
03760225714287IBS™G01 01291G01 012912022-05-09
03760225714294IBS™G01 01301G01 013012022-05-09
03760225714300IBS™G01 01311G01 013112022-05-09

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
00889797114820PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797114837PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
03701337614355QUANTUMIN2BONESHSN2024-12-13
00885556832271Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.HSN2022-12-22
00885556831892Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.HSN2022-12-21
00885556831939Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.HSN2022-12-21
00885556831946Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.HSN2022-12-21
00885556831953Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.HSN2022-12-21