FDA.reportPublic FDA data

Comprehensive® SRS

Primary DI
00880304540675
Brand
Comprehensive® SRS
Company
Biomet Orthopedics, LLC
Model
211226
Catalog number
211226
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDCProsthesis, Elbow, Constrained, CementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111746000
K173411000
K223631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111746000COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)Biomet, Inc.2011-12-15KWT
K173411000Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp2018-02-08PHX
K223631000Comprehensive Segmental Revision System(SRS)Biomet Orthopedics2023-07-12KWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304540675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304540675008803045406758803045406750880304540675

GMDN Terms#

Term, Definition table
TermDefinition
Humeral stem extension prosthesisA sterile implantable component of a total shoulder prosthesis intended to be fixed to the proximal end of a humeral stem when there has been a large resection of the humerus (e.g., due to trauma or tumour) to achieve the additional length required for connection to a humeral body. It is a modular arrangement of interlocking parts so the length can be configured intraoperatively. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti)] and is used in a modular shoulder replacement system.

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
Manufacturing date on label
true
Expiration date on label
true

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
00887868552113Signature ONE Software PackageOrthosoft IncKWS2026-10-27
00887868552113Signature ONE Software PackageOrthosoft IncMBF2026-10-27
00887868552113Signature ONE Software PackageOrthosoft IncKWT2026-10-27
00887868552113Signature ONE Software PackageOrthosoft IncPHX2026-10-27
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23