FDA.reportPublic FDA data

Arcos® One-Piece Revision System

Primary DI
00887868469459
Brand
Arcos® One-Piece Revision System
Company
Biomet Orthopedics, LLC
Model
110024879
Catalog number
110024879
Published
2022-04-23
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
KWLProsthesis, hip, hemi-, femoral, metal
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
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
OQHHip, semi-constrained, cemented, metal/polymer + additive, cemented
OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
PBIprosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
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
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2
OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, CementedOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2
PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151603000Arcos One-piece Femoral Revision SystemBiomet, Inc.2015-10-06LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868469459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868469459008878684694598878684694590887868469459

GMDN Terms#

Term, Definition table
TermDefinition
Femoral stem prosthesis trialA copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

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
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327380392TRIDENT IIHowmedica Osteonics Corp.KWZ2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.LZO2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.JDI2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.LPH2018-02-12
07613327345001Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345070Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345070Trident IIHowmedica Osteonics Corp.JDI2016-10-20