FDA.reportPublic FDA data

Taperloc Complete Micro Primary Femoral

Primary DI
00880304513532
Brand
Taperloc Complete Micro Primary Femoral
Company
Biomet Orthopedics, LLC
Model
51-107150
Catalog number
51-107150
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
JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)
KWHPROSTHESIS, TOE, CONSTRAINED, POLYMER
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
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Orthopedic3
KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)Orthopedic3
KWHProsthesis, Toe, Constrained, PolymerOrthopedic2
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
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110400000TAPERLOC COMPLETE MICROPLASTY STEMBiomet Manufacturing Corp2011-09-30KWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304513532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304513532008803045135328803045135320880304513532

GMDN Terms#

Term, Definition table
TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. 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

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
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707467Z1® Hip SystemZimmer, Inc.MEH2026-07-29
00889024707467Z1® Hip SystemZimmer, Inc.KWZ2026-07-29
00889024707467Z1® Hip SystemZimmer, Inc.LZO2026-07-29
00889024707467Z1® Hip SystemZimmer, Inc.KWY2026-07-29
09348215185428Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185435Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185442Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185459Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185466Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185473Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185480Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185497Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185503Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185510Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185527Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185534Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185664Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185671Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185688Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185695Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185701Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185718Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185725Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185732Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185749Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185756Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185763Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185770Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
04046964680878COREHIP EXTENDEDAesculap AGLZO2020-08-10
04046964681028COREHIP EXTENDEDAesculap AGLZO2020-08-10