FDA.reportPublic FDA data

ASCENT KNEE SYSTEM

Primary DI
00880304264618
Brand
ASCENT KNEE SYSTEM
Company
Biomet Orthopedics, LLC
Model
179406
Catalog number
179406
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWHPROSTHESIS, TOE, CONSTRAINED, POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWHProsthesis, Toe, Constrained, PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033489000
K994326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033489000AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWNBiomet, Inc.2004-06-02MBH
K994326000ASCENT KNEE SYSTEMBiomet Manufacturing, Inc.2000-01-07KWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304264618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304264618008803042646188803042646180880304264618

GMDN Terms#

Term, Definition table
TermDefinition
Coated knee femur prosthesisA sterile implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its 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)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVMBH2026-05-28
07613327014846TriathlonHowmedica Osteonics Corp.MBH2017-06-19
07613327000061INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000078INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000085INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000139INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000177INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000184INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000191INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000207INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000221INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000269INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000276INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000290INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000320INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000344INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000382INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000429INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000504INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000511INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327010138INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327010145INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327013498TriathlonHowmedica Osteonics Corp.MBH2015-09-24
07613327013504TriathlonHowmedica Osteonics Corp.MBH2015-09-24
07613327013535TriathlonHowmedica Osteonics Corp.MBH2015-09-24
07613327013566TriathlonHowmedica Osteonics Corp.MBH2015-09-24
07613327014471ScorpioHowmedica Osteonics Corp.MBH2015-09-24
07613327014495ScorpioHowmedica Osteonics Corp.MBH2015-09-24
07613327014525ScorpioHowmedica Osteonics Corp.MBH2015-09-24
07613327014532ScorpioHowmedica Osteonics Corp.MBH2015-09-24