Arcos® Modular Revision Hip System

Primary DI
00880304539259
Brand
Arcos® Modular Revision Hip System
Company
Biomet Orthopedics, LLC
Model
11-302109
Catalog number
11-302109
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDGProsthesis, hip, femoral component, cemented, metal
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
LWJProsthesis, hip, semi-constrained, metal/polymer, 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, calicum-phosphate
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
JDGProsthesis, Hip, Femoral Component, Cemented, MetalOrthopedic2
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
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, 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
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
K130063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130063000ARCOS TROCHANTER BUTTONBiomet, Inc.2013-04-19LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304539259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304539259008803045392598803045392590880304539259

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304737488Cartridge Thread Adapter1100301661100301662020-02-13
05019279925377Cobalt MV Bone Cement4024384024382015-11-28
00880304370456CEMENT NOZZLE4149914149912017-07-28
00880304370517OPTIVAC415441542017-07-28
00880304476783Cobalt MV with Gentamicin4024394024392015-11-28
00880304560789Cobalt Bone Cement4022824022822015-11-28
00880304560796Cobalt HV with Gentamicin4022834022832015-11-28
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295518761SMARTSETDEPUY (IRELAND)KWY2026-09-10
00190446153917DJO SURGICALEncore Medical, L.P.LWJ2017-03-30
00190446153917DJO SURGICALEncore Medical, L.P.LZO2017-03-30
00190446153917DJO SURGICALEncore Medical, L.P.KWZ2017-03-30
00190446153924DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153924DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153924DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153931DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153931DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153931DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153948DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153948DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153948DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153955DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153955DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153955DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153962DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153962DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153962DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153979DJO SURGICALEncore Medical, L.P.KWZ2017-03-03
00190446153979DJO SURGICALEncore Medical, L.P.LWJ2017-03-03
00190446153979DJO SURGICALEncore Medical, L.P.LZO2017-03-03
00190446153986DJO SURGICALEncore Medical, L.P.KWZ2017-03-03
00190446153986DJO SURGICALEncore Medical, L.P.LZO2017-03-03
00190446153986DJO SURGICALEncore Medical, L.P.LWJ2017-03-03
00190446153993DJO SURGICALEncore Medical, L.P.LWJ2017-03-03
00190446153993DJO SURGICALEncore Medical, L.P.KWZ2017-03-03
00190446153993DJO SURGICALEncore Medical, L.P.LZO2017-03-03
00190446154006DJO SURGICALEncore Medical, L.P.LZO2017-03-03
00190446154006DJO SURGICALEncore Medical, L.P.LWJ2017-03-03