FDA.reportPublic FDA data

Klassic HD Hooded Acetabular Insert with XLPE Poly

Primary DI
00814703015274
Brand
Klassic HD Hooded Acetabular Insert with XLPE Poly
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
3508.44.028
Device description
Hooded Acetabular Insert with XLPE Poly, 28mm head, size 44mm
Published
2018-06-12
Public version status
New
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
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180929000Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.2018-05-09LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814703015274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814703015274008147030152748147030152740814703015274

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

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
Ethylene Oxide

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
00889024707160G7® Vivacit-E®Zimmer, Inc.OQG2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCOQG2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.OQG2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCOQG2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.OQG2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCOQG2026-09-30
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000095Triple Taper Stem Standard Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000101Triple Taper Stem High Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000118Triple Taper Stem Standard Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000125Triple Taper Stem High Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22