Initia Total Hip System

GUDID 04580810058553

"STDHO LINER 40-60/64 Size:40-60/62/64 Type:Flat, HO 40mm I.D. 60/62/64mm O.D."

KYOCERA MEDICAL CORPORATION

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04580810058553
• NIH Device Record Key: b964452c-8dd5-4434-8622-6caee33473b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Initia Total Hip System
• Version Model Number: GMH02-200186
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547898307416 [Previous]
GS1	04580810058553 [Primary]

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-27
• Device Publish Date: 2026-02-19

On-Brand Devices [Initia Total Hip System]

• 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