FDA.reportPublic FDA data

BIOLOX CONTOURA Ceramic Femoral Head

Primary DI
00814703016844
Brand
BIOLOX CONTOURA Ceramic Femoral Head
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
3206.32.000
Device description
Contura Femoral Head, 32mm head, Neu head length
Published
2019-09-16
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
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191399000BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.2019-08-28LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814703016844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814703016844008147030168448147030168440814703016844

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic femoral head prosthesisA sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). 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 replacement. 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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify00The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)486-6070udi@tjoinc.com

Regulatory Flags#

DUNS number
078416717
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094692803Klassic Blade Femoral Broach, Line-To-Line, size 0SRI-10054.002026-07-27
00810094692810Klassic Blade Femoral Broach, Line-To-Line, size 1SRI-10054.012026-07-27
00810094692827Klassic Blade Femoral Broach, Line-To-Line, size 2SRI-10054.022026-07-27
00810094692834Klassic Blade Femoral Broach, Line-To-Line, size 3SRI-10054.032026-07-27
00810094692841Klassic Blade Femoral Broach, Line-To-Line, size 4SRI-10054.042026-07-27
00810094692858Klassic Blade Femoral Broach, Line-To-Line, size 5SRI-10054.052026-07-27
00810094692865Klassic Blade Femoral Broach, Line-To-Line, size 6SRI-10054.062026-07-27
00810094692872Klassic Blade Femoral Broach, Line-To-Line, size 7SRI-10054.072026-07-27
00810094692889Klassic Blade Femoral Broach, Line-To-Line, size 8SRI-10054.082026-07-27
00810094692896Klassic Blade Femoral Broach, Line-To-Line, size 9SRI-10054.092026-07-27
00810094692902Klassic Blade Femoral Broach, Line-To-Line, size 10SRI-10054.102026-07-27
00810094692919Klassic Blade Femoral Broach, Line-To-Line, size 11SRI-10054.112026-07-27
00810094692926Klassic Blade Femoral Broach, Line-To-Line, size 12SRI-10054.122026-07-27
00810094692698Modular Frog Eyes2263.00.0002026-06-09
00810094692704Distal Femoral Cut Block Connector2174.00.0002026-06-09
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mm2264.00.0002026-06-09
00810094692933Magnet Spacer, 5mm2027.00.0002026-06-09
00810094692940AP Sizer with Short LegsSRI-100502026-05-15
00810094692728CR Femoral Trial, Grit BlastedSRI-10051.012026-02-05
00810094692735CR Femoral Trial, Grit BlastedSRI-10051.022026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24