FDA.reportPublic FDA data

KIRSCHNER HIP SYSTEM

Primary DI
00880304569522
Brand
KIRSCHNER HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
532805000
Catalog number
532805000
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K871401000
K912922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871401000KIRSCHNER MODULAR HIP SYSTEMKirschner Medical Corp.1987-05-18JDI
K912922000DIMENSION-HA HIP PROSTHESISKirschner Medical Corp.1991-10-04MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304569522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304569522008803045695228803045695220880304569522

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
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00843575126818Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126825Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126832Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126849Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126856Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126863Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126870Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126887Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126894Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126900Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126917Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126924Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126931Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126948Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126955Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126962Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126979Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126986Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128621Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128638Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128645Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128652Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128669Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
07611996142334POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996074901SL-PLUSSmith & Nephew, Inc.JDI2016-08-19