FDA.reportPublic FDA data

Maxim Accel Knee System

Primary DI
00880304849198
Brand
Maxim Accel Knee System
Company
Biomet Orthopedics, LLC
Model
SSI003710
Catalog number
SSI003710
Published
2017-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023546000MAXIM ACCEL KNEE SYSTEMBiomet, Inc.2003-01-17JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304849198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304849198008803048491988803048491980880304849198

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trialA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height13Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707726SolidLok®2810-01-0212810010212026-06-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017262819EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262826EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262833EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262840EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262857EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262864EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262871EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262888EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262895EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262901EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262918EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262925EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262932EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262949EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262956EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262963EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262970EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262987EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262994EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263007EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263014EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263021EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263038EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263045EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263052EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263069EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263076EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263083EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263090EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263106EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10