FDA.reportPublic FDA data

KIRSCHNER HIP SYSTEM

Primary DI
00880304569553
Brand
KIRSCHNER HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
533201000
Catalog number
533201000
Published
2015-10-24
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
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912922000DIMENSION-HA HIP PROSTHESISKirschner Medical Corp.1991-10-04MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304569553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304569553008803045695538803045695530880304569553

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisA sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal (e.g., titanium alloy). 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 with a bipolar component as part of a partial hip arthroplasty. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

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
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
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899177United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899184United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899191United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899207United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899214United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899221United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899238United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899245United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899252United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886910896United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913361Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913378Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913385Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913392Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913408Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15