FDA.reportPublic FDA data

MATRIX

Primary DI
03596010007391
Brand
MATRIX
Company
Smith & Nephew, Inc.
Model
MH0002
Catalog number
MH0002
Device description
MATRIX TITANIUM TAPER SLEEVE +12MM
Published
2015-08-29
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
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211176000
K900628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH
K900628000MODULAR HIP SYSTEMRichards Medical Co., Inc.1990-05-09LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010007391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010007391035960100073913596010007391

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30
00885556236949STRUCSURE7178057178052016-04-08
00885556236994STRUCSURE7178087178082016-04-08
00885556237045STRUCSURE7178167178162016-04-08
00885556838211Total Foot System 2280500728050072023-04-18
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707160G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24