Class Class II
ACTERA™ hip system (K231178)
Description
ACTERA™ hip system by Conformis, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231178
Clearance Date2023-05-23
Clearance TypeSpecial
Product CodeMEH
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231178
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ACTERA™ hip system (K231178) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221104 | Actera hip system | Conformis, Inc. | 2022 |
| K202484 | Cordera Hip System | Conformis, Inc. | 2020 |
| K192198 | Conformis Hip System | Conformis, Inc. | 2019 |
Trace the full predicate network for K231178
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.