FDA.reportPublic FDA data

Arcos® Revision Hip Instrumentation

Primary DI
05019279431526
Brand
Arcos® Revision Hip Instrumentation
Company
Biomet Uk Ltd
Model
31-301918
Catalog number
31-301918
Published
2020-05-08
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100469000ARCOS INTERLOCKING DISTAL STEMSBiomet Manufacturing Corp2010-12-07KWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05019279431526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05019279431526050192794315265019279431526

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

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
219322575
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024682481Oxford® Partial Knee System1101101031101101032026-09-04
00889024682498Oxford® Partial Knee System1101101041101101042026-09-04
00889024682504Oxford® Partial Knee System1101101051101101052026-09-04
00889024682528Oxford® Partial Knee System1101101071101101072026-09-04
00889024682535Oxford® Partial Knee System1101101081101101082026-09-04
00889024682542Oxford® Partial Knee System1101101091101101092026-09-04
00889024682559Oxford® Partial Knee System1101102031101102032026-09-04
00889024682566Oxford® Partial Knee System1101102041101102042026-09-04
00889024682573Oxford® Partial Knee System1101102051101102052026-09-04
00889024682580Oxford® Partial Knee System1101102061101102062026-09-04
00889024682603Oxford® Partial Knee System1101102081101102082026-09-04
00889024682610Oxford® Partial Knee System1101102091101102092026-09-04
00889024682634Oxford® Partial Knee System1101103041101103042026-09-04
00889024682641Oxford® Partial Knee System1101103051101103052026-09-04
00889024682665Oxford® Partial Knee System1101103071101103072026-09-04
00889024682672Oxford® Partial Knee System1101103081101103082026-09-04
00889024682696Oxford® Partial Knee System1101104031101104032026-09-04
00889024682719Oxford® Partial Knee System1101104051101104052026-09-04
00889024682733Oxford® Partial Knee System1101104071101104072026-09-04
00889024682757Oxford® Partial Knee System1101104091101104092026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327380392TRIDENT IIHowmedica Osteonics Corp.MEH2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.LPH2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.JDI2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.LZO2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.KWZ2018-02-12
07613327345001Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LZO2016-10-20