FDA 510(k)

POLARSTEM Cemented Femoral Stem

K-Number: K203175 · 2021-07-22

Decision Date2021-07-22

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

POLARSTEM Cemented Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K203175. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARSTEM Cemented Femoral Stem?

POLARSTEM Cemented Femoral Stem is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K203175.

When did POLARSTEM Cemented Femoral Stem receive FDA 510(k) clearance?

POLARSTEM Cemented Femoral Stem received FDA 510(k) clearance on 2021-07-22, under 510(k) number K203175.

Who is the listed applicant for POLARSTEM Cemented Femoral Stem?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLARSTEM Cemented Femoral Stem?

The FDA product code for POLARSTEM Cemented Femoral Stem is LZO.

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Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: LZO)

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG K260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH K252401implaFit® short stemsImplantcast GmbH K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.