FDA.reportPublic FDA data

STERIZO Total Hip System

Primary DI
B565M221554281
Brand
STERIZO Total Hip System
Company
CPM Medical Consultants, LLC
Model
Rev A
Catalog number
M-2215-5428
Device description
Liner, Elevated Face Sz 54x28
Published
2022-02-15
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143314000Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC2015-02-27LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B565M221554281PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. 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 articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
972-331-5860xx@xx.xx

Regulatory Flags#

DUNS number
017138000
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B565OS328028L1Fuse ULTRA FOOT PLATING SYSTEMOS328028LOS328028L2026-04-17
B565M32205016L1STERIZO Total Knee SystemM-3220-5016LM-3220-5016L2026-02-26
B565M32205016S1STERIZO Total Knee SystemM-3220-5016SM-3220-5016S2026-02-26
B565OS20160960Fuse ULTRA FOOT PLATING SYSTEMOS2016096OS20160962025-05-29
B565OS4225081Fuse ULTRA FOOT PLATING SYSTEMOS422508OS4225082025-08-01
B565OS4225101Fuse ULTRA FOOT PLATING SYSTEMOS422510OS4225102025-08-01
B565OS4225121Fuse ULTRA FOOT PLATING SYSTEMOS422512OS4225122025-08-01
B565OS4225141Fuse ULTRA FOOT PLATING SYSTEMOS422514OS4225142025-08-01
B565OS4225161Fuse ULTRA FOOT PLATING SYSTEMOS422516OS4225162025-08-01
B565OS4225181Fuse ULTRA FOOT PLATING SYSTEMOS422518OS4225182025-08-01
B565OS4225201Fuse ULTRA FOOT PLATING SYSTEMOS422520OS4225202025-08-01
B565OS4225221Fuse ULTRA FOOT PLATING SYSTEMOS422522OS4225222025-08-01
B565OS4225241Fuse ULTRA FOOT PLATING SYSTEMOS422524OS4225242025-08-01
B565OS4225261Fuse ULTRA FOOT PLATING SYSTEMOS422526OS4225262025-08-01
B565OS4225281Fuse ULTRA FOOT PLATING SYSTEMOS422528OS4225282025-08-01
B565OS4225301Fuse ULTRA FOOT PLATING SYSTEMOS422530OS4225302025-08-01
B565OS4226081Fuse ULTRA FOOT PLATING SYSTEMOS422608OS4226082025-08-01
B565OS4226101Fuse ULTRA FOOT PLATING SYSTEMOS422610OS4226102025-08-01
B565OS4226121Fuse ULTRA FOOT PLATING SYSTEMOS422612OS4226122025-08-01
B565OS4226141Fuse ULTRA FOOT PLATING SYSTEMOS422614OS4226142025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09