Cleared Traditional

Bone Screws dia. 5,0 mm

K210717 · Lima Corporate S.P.A. · Orthopedic

Jul 2021

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K210717 is an FDA 510(k) clearance for the Bone Screws dia. 5,0 mm, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on July 12, 2021, 124 days after receiving the submission on March 10, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K210717 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2021
Decision Date	July 12, 2021
Days to Decision	124 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PHX — Shoulder Prosthesis, Reverse Configuration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.