Cleared Special

Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts

K232426 · Conformis, Inc. · Orthopedic

Sep 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K232426 is an FDA 510(k) clearance for the Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on September 8, 2023, 28 days after receiving the submission on August 11, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K232426 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2023
Decision Date	September 08, 2023
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565