FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523105427
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
Bipolar Hip
Catalog number
1416-028-046
Device description
Bipolar Implant 46mm OD - 28mm ID
Published
2015-10-28
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

Product Codes#

Code, Name table
CodeName
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131354000RENOVIS BIPOLAR HIP SYSTEMRenovis Surgical Technologies, LLC2013-09-19KWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841523105427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523105427008415231054278415231054270841523105427

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head bipolar componentA sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116995646
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841523183944Kyocera Medical Technologies, Inc.Initia T33535-851-0122026-08-21
00841523183999Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5112026-08-21
00841523184002Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5132026-08-21
00841523184019Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5152026-08-21
00841523184026Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5172026-08-21
00841523184033Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5192026-08-21
00841523184040Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5212026-08-21
00841523185337Kyocera Medical Technologies, Inc.Tesera-K-SC3061-011-0162026-08-21
00841523183081Kyocera Medical Technologies, Inc.Tesera-K XL2173-001-0032026-08-07
00841523183746Kyocera Medical Technologies, Inc.Tesera-K XL3073-005-0002026-08-07
00841523185030Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1082026-08-07
00841523185047Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1102026-08-07
00841523185054Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1122026-08-07
00841523185061Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1142026-08-07
00841523185078Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1162026-08-07
00841523185092Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-2102026-08-07
00841523185108Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-2122026-08-07
00841523185139Kyocera Medical Technologies, Inc.Tesera-K XL2173-022-1082026-08-07
00841523185146Kyocera Medical Technologies, Inc.Tesera-K XL2173-022-1102026-08-07
00841523185153Kyocera Medical Technologies, Inc.Tesera-K XL2173-022-1122026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442100200SignatureMaterialise NVKWY2026-09-24
E31442100300SignatureMaterialise NVKWY2026-09-24
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000095Triple Taper Stem Standard Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000101Triple Taper Stem High Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000118Triple Taper Stem Standard Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000125Triple Taper Stem High Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000132Triple Taper Stem Standard Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000149Triple Taper Stem High Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000156Triple Taper Stem Standard Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000163Triple Taper Stem High Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22