FDA.report

510(k) K231178

Device
ACTERA™ hip system
Applicant
Conformis, Inc.
510(k) number
K231178
Product code
MEH
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-23
Date received
2023-04-26
Regulation
888.3353
Classification name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Mary Kruitwagen
Address
600 Technology Park Dr. Fourth Floor Billerica MA US 01821 01821

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00810933031435BROACH, FEMORAL, ACTERA, SIZE 00Conformis, Inc.2023-07-05
00810933031534BROACH, FEMORAL, ACTERA, SIZE 10Conformis, Inc.2023-07-05
00810933031541BROACH, FEMORAL, ACTERA, SIZE 11Conformis, Inc.2023-07-05
00810933031558BROACH, FEMORAL, ACTERA, SIZE 12Conformis, Inc.2023-07-05
00810933031626ACTERA HIP TRIAL NECK, REUSABLE, SIZE 10-11-12 STANDARDConformis, Inc.2023-07-05
00810933031633ACTERA HIP TRIAL NECK, REUSABLE SIZE 10-11-12 HIGH OFFSETConformis, Inc.2023-07-05
M572HEA050A000011ACTERA SINGLE USE TRIAL NECK GROUP A STANDARD AND HIGH OFFSETConformis, Inc.2023-07-05
M572HEA050C000011ACTERA SINGLE USE TRIAL NECK GROUP C STANDARD AND HIGH OFFSETConformis, Inc.2023-07-05
M572HEA050D000011ACTERA SINGLE USE TRIAL NECK GROUP D STANDARD AND HIGH OFFSETConformis, Inc.2023-07-05
M572HES0340010011ACTERAConformis, Inc.2023-06-26
M572HES0340011011ACTERAConformis, Inc.2023-06-26
M572HES0340009011ACTERAConformis, Inc.2023-06-26
M572HES0340008011ACTERAConformis, Inc.2023-06-26
M572HES0340007011ACTERAConformis, Inc.2023-06-26
M572HES0340006011ACTERAConformis, Inc.2023-06-26
M572HES0340005011ACTERAConformis, Inc.2023-06-26
M572HES0340004011ACTERAConformis, Inc.2023-06-26
M572HES0340003011ACTERAConformis, Inc.2023-06-26
M572HES0340002011ACTERAConformis, Inc.2023-06-26
M572HES0340001011ACTERAConformis, Inc.2023-06-26
M572HES0340000011ACTERAConformis, Inc.2023-06-26
M572HES03410CS011ACTERAConformis, Inc.2023-06-26
M572HES03412US011ACTERAConformis, Inc.2023-06-26
M572HES03412UH011ACTERAConformis, Inc.2023-06-26
M572HES03412CS011ACTERAConformis, Inc.2023-06-26
M572HES03412CH011ACTERAConformis, Inc.2023-06-26
M572HES03411US011ACTERAConformis, Inc.2023-06-26
M572HES03411UH011ACTERAConformis, Inc.2023-06-26
M572HES03411CS011ACTERAConformis, Inc.2023-06-26
M572HES03411CH011ACTERAConformis, Inc.2023-06-26

Other 510(k) Records For Product Code MEH

510(k)DeviceApplicantDecision date
K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG2025-11-05
K251166Mfinity Femoral SystemMedacta International S.A.2025-06-13
K251052Trivicta® Hip StemOrtho Development Corp.2025-05-22
K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation2025-05-01
K243839Alteon® HA Femoral StemsExactech, Inc.2025-03-10
K243162World LinerSignature Orthopaedics Pty, Ltd.2024-11-25
K241472Icona Hip StemCorin U.S.A. Limited2024-10-03
K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix2024-09-13
K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.2024-08-01
K233758Trivicta™ Hip StemOrtho Development Corp.2024-03-08
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalDepuy Ireland UC2024-01-19
K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.2023-01-13
K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022-08-11
K221104Actera™ hip systemConformis, Inc.2022-08-04
K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.2022-01-07