Cleared Traditional

Actera? hip system

K221104 · Conformis, Inc. · Orthopedic

Aug 2022

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K221104 is an FDA 510(k) clearance for the Actera? hip system, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on August 4, 2022, 112 days after receiving the submission on April 14, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K221104 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2022
Decision Date	August 04, 2022
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353