Cleared Traditional

SpaceFlex Acetabular Cup

K223441 · G21, S.R.L. · Orthopedic

Mar 2023

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K223441 is an FDA 510(k) clearance for the SpaceFlex Acetabular Cup, a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on March 23, 2023, 129 days after receiving the submission on November 14, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K223441 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2022
Decision Date	March 23, 2023
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390