Cleared Special

K192198 - Conformis Hip System
(FDA 510(k) Clearance)

K192198 · Conformis, Inc. · Orthopedic

Nov 2019

Decision

85d

Days

Class 2

Risk

K192198 is an FDA 510(k) clearance for the Conformis Hip System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on November 6, 2019, 85 days after receiving the submission on August 13, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K192198 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2019
Decision Date	November 06, 2019
Days to Decision	85 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358