| Primary Device ID | 04580810067968 |
| NIH Device Record Key | 11a4a834-e9c0-4ca6-a5b3-f0d90956f5e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Initia Total Hip System |
| Version Model Number | TJ39953-1 |
| Company DUNS | 691363290 |
| Company Name | KYOCERA MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04547898735318 [Previous] |
| GS1 | 04580810067968 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
[04580810067968]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-03 |
| Device Publish Date | 2026-02-23 |
| 04580810059116 | INITIA STEM HO #11 "Size: #11 Stem: High offset Taper: 12/14 Stem length: 119mm Neck length: 40 |
| 04580810059109 | INITIA STEM HO #10 "Size: #10 Stem: High offset Taper: 12/14 Stem length: 117mm Neck length: 40 |
| 04580810059093 | INITIA STEM HO #9 "Size: #9 Stem: High offset Taper: 12/14 Stem length: 115mm Neck length: 39mm |
| 04580810059079 | INITIA STEM HO #7 "Size: #7 Stem: High offset Taper: 12/14 Stem length: 111mm Neck length: 40mm |
| 04580810059062 | INITIA STEM HO #6.5 "Size: #6.5 Stem: High offset Taper: 12/14 Stem length: 109mm Neck length: 3 |
| 04580810059055 | INITIA STEM HO #6 "Size: #6 Stem: High offset Taper: 12/14 Stem length: 107mm Neck length: 39mm |
| 04580810059017 | INITIA STEM HO #4 "Size: #4 Stem: High offset Taper: 12/14 Stem length: 102mm Neck length: 37mm |
| 04580810058928 | INITIA STEM STD #11 "Size: #11 Stem: Standard offset Taper: 12/14 Stem length: 119mm Neck length |
| 04580810058874 | INITIA STEM STD #6.5 "Size: #6.5 Stem: Standard offset Taper: 12/14 Stem length: 109mm Neck leng |
| 04580810058294 | STD LINER 36-60/64 "Size:36-60/62/64 Type:Flat 36mm I.D. 60/62/64mm O.D." |
| 04580810058263 | STD LINER 36-50 "Size:36-50 Type:Flat 36mm I.D. 50mm O.D." |
| 04580810056429 | INITIA SHELL 56-3H "Size: φ56MM O.D. Type: 3 HOLE" |
| 04580810056412 | INITIA SHELL 54-3H "Size: φ54MM O.D. Type: 3 HOLE" |
| 04580810056405 | INITIA SHELL 52-3H "Size: φ52MM O.D. Type: 3 HOLE" |
| 04580810056252 | INITIA SHELL 58-7H "Size: φ58MM O.D. Type: 7 HOLE" |
| 04580810056221 | INITIA SHELL 52-7H "Size: φ52MM O.D. Type: 7 HOLE" |
| 04580810059413 | "METAL HEAD 44 +10.5 Size: φ44MM O.D. Offset: +10.5mm Taper: 12/14" |
| 04580810059406 | "METAL HEAD 44 +7 Size: φ44MM O.D. Offset: +7mm Taper: 12/14" |
| 04580810059390 | "METAL HEAD 44 +3.5 Size: φ44MM O.D. Offset: +3.5mm Taper: 12/14" |
| 04580810059383 | "METAL HEAD 44 +0 Size: φ44MM O.D. Offset: +0mm Taper: 12/14" |
| 04580810059376 | "METAL HEAD 44 -3.5 Size: φ44MM O.D. Offset: -3.5mm Taper: 12/14" |
| 04580810059369 | "METAL HEAD 40 +10.5 Size: φ40MM O.D. Offset: +10.5mm Taper: 12/14" |
| 04580810059352 | "METAL HEAD 40 +7 Size: φ40MM O.D. Offset: +7mm Taper: 12/14" |
| 04580810059345 | "METAL HEAD 40 +3.5 Size: φ40MM O.D. Offset: +3.5mm Taper: 12/14" |
| 04580810059338 | "METAL HEAD 40 +0 Size: φ40MM O.D. Offset: +0mm Taper: 12/14" |
| 04580810059321 | "METAL HEAD 40 -3.5 Size: φ40MM O.D. Offset: -3.5mm Taper: 12/14" |
| 04580810059314 | "METAL HEAD 36 +10.5 Size: φ36MM O.D. Offset: +10.5mm Taper: 12/14" |
| 04580810059307 | "METAL HEAD 36 +9 Size: φ36MM O.D. Offset: +9mm Taper: 12/14" |
| 04580810059291 | "METAL HEAD 36 +7 Size: φ36MM O.D. Offset: +7mm Taper: 12/14" |
| 04580810059284 | "METAL HEAD 36 +3.5 Size: φ36MM O.D. Offset: +3.5mm Taper: 12/14" |
| 04580810059277 | "METAL HEAD 36 +0 Size: φ36MM O.D. Offset: +0mm Taper: 12/14" |
| 04580810059260 | "METAL HEAD 36 -3.5 Size: φ36MM O.D. Offset: -3.5mm Taper: 12/14" |
| 04580810059253 | "METAL HEAD 32 +7 Size: φ32MM O.D. Offset: +7mm Taper: 12/14" |
| 04580810059246 | "METAL HEAD 32 +3.5 Size: φ32MM O.D. Offset: +3.5mm Taper: 12/14" |
| 04580810059239 | "METAL HEAD 32 +0 Size: φ32MM O.D. Offset: +0mm Taper: 12/14" |
| 04580810059222 | "METAL HEAD 32 -3.5 Size: φ32MM O.D. Offset: -3.5mm Taper: 12/14" |
| 04580810059215 | "METAL HEAD 28 +7 Size: φ28MM O.D. Offset: +7mm Taper: 12/14" |
| 04580810059208 | "METAL HEAD 28 +5 Size: φ28MM O.D. Offset: +5mm Taper: 12/14" |
| 04580810059192 | "METAL HEAD 28 +3.5 Size: φ28MM O.D. Offset: +3.5mm Taper: 12/14" |
| 04580810059185 | "METAL HEAD 28 +0 Size: φ28MM O.D. Offset: +0mm Taper: 12/14" |
| 04580810059178 | "METAL HEAD 28 -3.5 Size: φ28MM O.D. Offset: -3.5mm Taper: 12/14" |
| 04580810059161 | "METAL HEAD 26 +3.5 Size: φ26MM O.D. Offset: +3.5mm Taper: 12/14" |
| 04580810059154 | "METAL HEAD 26 +0 Size: φ26MM O.D. Offset: +0mm Taper: 12/14" |
| 04580810059147 | "METAL HEAD 26 -3.5 Size: φ26MM O.D. Offset: -3.5mm Taper: 12/14" |
| 04580810059130 | "METAL HEAD 22 +3.5 Size: φ22MM O.D. Offset: +3.5mm Taper: 12/14" |
| 04580810059123 | "METAL HEAD 22 +0 Size: φ22MM O.D. Offset: +0mm Taper: 12/14" |
| 04580810058812 | "INITIA STEM STD #3.5 Size: #3.5 Stem: Standard offset Taper: 12/14 Stem length: 99mm Neck lengt |
| 04580810058805 | "INITIA STEM STD #3 Size: #3 Stem: Standard offset Taper: 12/14 Stem length: 99mm Neck length: 3 |
| 04580810058799 | "INITIA STEM STD #2.5 Size: #2.5 Stem: Standard offset Taper: 12/14 Stem length: 97mm Neck lengt |
| 04580810058782 | "INITIA STEM STD #2 Size: #2 Stem: Standard offset Taper: 12/14 Stem length: 97mm Neck length: 3 |