FDA.reportPublic FDA data

ACTERA

Primary DI
M572HES0340007011
Brand
ACTERA
Company
Conformis, Inc.
Model
HES-034-0007-01
Catalog number
HES-034-0007
Device description
HIPRX STEM SIZE 7 RIGHT OR LEFT
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

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
M572HES0340007011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, one-pieceA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
808821883
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M572TCR000D00F021Identity Imprint CR Knee Replacement SystemTCR-000-D00F1TCR-000-D00F2024-06-26
M572TCR000D00T021Identity Imprint CR Knee Replacement SystemTCR-000-D00T1TCR-000-D00T2024-06-26
M572TPS000D00F021Identity Imprint PS Knee Replacement SystemTPS-000-D00F1TPS-000-D00F2024-06-26
M572TCR302T07S011Identity Imprint Porous CR TCR-302-T07S-01TCR-302-T07S2024-01-24
00810933031817Calcar Planer Adapter Drop-in1080-7001080-7002023-12-05
M572POV0123208011Identity Imprint Porous CR POV-012-3208-01POV-012-32082023-09-08
M572POV0123509011Identity Imprint Porous CR POV-012-3509-01POV-012-35092023-09-08
M572POV0123809011Identity Imprint Porous CR POV-012-3809-01POV-012-38092023-09-08
M572POV0124110011Identity Imprint Porous CR POV-012-4110-01POV-012-41102023-09-08
M572POV0124411011Identity Imprint Porous CR POV-012-4411-01POV-012-44112023-09-08
M572TCR102F01S011Identity Imprint Porous CRTCR-102-F01S-01TCR-102-F01S2023-09-08
M572TCR102F02N011Identity Imprint Porous CR TCR-102-F02N-01TCR-102-F02N2023-09-08
M572TCR102F02S011Identity Imprint Porous CR TCR-102-F02S-01TCR-102-F02S2023-09-08
M572TCR102F03N011Identity Imprint Porous CR TCR-102-F03N-01TCR-102-F03N2023-09-08
M572TCR102F03S011Identity Imprint Porous CR TCR-102-F03S-01TCR-102-F03S2023-09-08
M572TCR102F04N011Identity Imprint Porous CR TCR-102-F04N-01TCR-102-F04N2023-09-08
M572TCR102F04S011Identity Imprint Porous CR TCR-102-F04S-01TCR-102-F04S2023-09-08
M572TCR102F05N011Identity Imprint Porous CR TCR-102-F05N-01TCR-102-F05N2023-09-08
M572TCR102F05S011Identity Imprint Porous CR TCR-102-F05S-01TCR-102-F05S2023-09-08
M572TCR102F06N011Identity Imprint Porous CR TCR-102-F06N-01TCR-102-F06N2023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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