FDA.reportPublic FDA data

ACTERA

Primary DI
M572HES03412UH011
Brand
ACTERA
Company
Conformis, Inc.
Model
HES-034-12UH-01
Catalog number
HES-034-12UH
Device description
FEMORAL HIP STEM UNCOLLARED SZ 12, HIGH OFFSET
Published
2023-06-26
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
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231178000ACTERA™ hip systemConformis, Inc.2023-05-23MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M572HES03412UH011PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-345-9001customer-service@conformis.com

Regulatory Flags#

DUNS number
808821883
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810933031114Cordera Hip System Offset Cup Impactor, Enztec1080-6461080-6462022-03-07
00810933031183Cordera Hip System Radel Liner Impactors 28mm1080-6551080-6552022-03-07
00810933031190Cordera Hip System Radel Liner Impactors 32mm1080-6561080-6562022-03-07
00810933031206Cordera Hip System Radel Liner Impactors 36mm1080-6571080-6572022-03-07
00810933031213Cordera Hip System Radel Liner Impactors 40mm1080-6581080-6582022-03-07
00810933031220Cordera Hip System T-handle Quick Connect1080-6591080-6592022-03-07
00810933031237Cordera Hip System OrthoGroup Cup Impactor1080-6601080-6602022-03-07
00850268007187iTotal® Impactor Head1080-5412016-10-24
00850268007194iTotal® Impactor Head1080-5352016-10-24
00850268007200iTotal® CR Tibial Tray Impactor Tip1080-5362016-10-24
00850268007217iTotal® PS Tibial Tray Impactor Tip1080-5422016-10-24
00850268007224iTotal® Poly Impactor Tip1080-5242016-10-24
M572HDL060C24S011iTotal® Hip Replacement SystemHDL060C24S01HDL060C24S2018-08-06
M572HDL060D24S011iTotal® Hip Replacement SystemHDL060D24S01HDL060D24S2018-07-30
M572HDL060D34S011iTotal® Hip Replacement SystemHDL060D34S01HDL060D34S2018-08-06
M572HDL060E24S011iTotal® Hip Replacement SystemHDL060E24S01HDL060E24S2018-08-06
M572HDL060E34S011iTotal® Hip Replacement SystemHDL060E34S01HDL060E34S2018-08-06
M572HDL060F24S011iTotal® Hip Replacement SystemHDL060F24S01HDL060F24S2018-08-06
M572HDL060F34S011iTotal® Hip Replacement SystemHDL060F34S01HDL060F34S2018-08-06
M572HDL060C10S011iTotal® Hip Replacement SystemHDL060C10S01HDL060C10S2018-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713666G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713673G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713680G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713697G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713703G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713734G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713741G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713758G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713765G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713772G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713789G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713796G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713802G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713819G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03
00889024713826G7® TM Acetabular SystemZimmer, Inc.OQG2026-11-03