FDA.reportPublic FDA data

Regenerex®

Primary DI
00887868252235
Brand
Regenerex®
Company
Biomet Orthopedics, LLC
Model
184603
Catalog number
184603
Published
2018-07-23
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
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072336000REGENEREX POROUS TITANIUM SLEEVE AUGMENTSBiomet Manufacturing Corp2007-11-05JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868252235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868252235008878682522358878682522350887868252235

GMDN Terms#

Term, Definition table
TermDefinition
Knee arthroplasty wedgeA sterile device designed to augment the implantation of a knee femur or tibia prosthesis by acting as a space-filler adjacent to the prosthesis, typically to replace lost bone. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].

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
09348215158828World Knee MC Poly Insert - Size 8 - 10mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158835World Knee MC Poly Insert - Size 8 - 11mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158842World Knee MC Poly Insert - Size 8 - 12mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158859World Knee MC Poly Insert - Size 8 - 13mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158866World Knee MC Poly Insert - Size 8 - 14mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158873World Knee MC Poly Insert - Size 8 - 15mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158880World Knee MC Poly Insert - Size 8 - 16mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158897World Knee MC Poly Insert - Size 8 - 17mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158903World Knee MC Poly Insert - Size 8 - 18mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158910World Knee MC Poly Insert - Size 8 - 10mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158927World Knee MC Poly Insert - Size 8 - 11mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158934World Knee MC Poly Insert - Size 8 - 12mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158941World Knee MC Poly Insert - Size 8 - 13mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158958World Knee MC Poly Insert - Size 8 - 14mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158965World Knee MC Poly Insert - Size 8 - 15mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158972World Knee MC Poly Insert - Size 8 - 16mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158989World Knee MC Poly Insert - Size 8 - 17mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158996World Knee MC Poly Insert - Size 8 - 18mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160265World Knee MC Vit-E Poly Insert - Size 7 - 10mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160272World Knee MC Vit-E Poly Insert - Size 7 - 11mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160289World Knee MC Vit-E Poly Insert - Size 7 - 12mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160296World Knee MC Vit-E Poly Insert - Size 7 - 13mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160302World Knee MC Vit-E Poly Insert - Size 7 - 14mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160319World Knee MC Vit-E Poly Insert - Size 7 - 15mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160326World Knee MC Vit-E Poly Insert - Size 7 - 16mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160333World Knee MC Vit-E Poly Insert - Size 7 - 17mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160340World Knee MC Vit-E Poly Insert - Size 7 - 18mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160357World Knee MC Vit-E Poly Insert - Size 7 - 10mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160364World Knee MC Vit-E Poly Insert - Size 7 - 11mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160371World Knee MC Vit-E Poly Insert - Size 7 - 12mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09