Cleared Traditional

K221758 - SMR Stemless Anatomic (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221758 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
274d
Days
Class 2
Risk

K221758 is an FDA 510(k) clearance for the SMR Stemless Anatomic. Classified as Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (product code PKC), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Villanova Di San Daniele Del Friuli, IT). The FDA issued a Cleared decision on March 17, 2023 after a review of 274 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Lima Corporate S.P.A. devices

Submission Details

510(k) Number K221758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2022
Decision Date March 17, 2023
Days to Decision 274 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 122d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Mcra, LLC
David McGurl

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

All 18
Devices cleared under the same product code (PKC) and FDA review panel - the closest regulatory comparables to K221758.
FX V135 EASYTECH® Shoulder System
K254154 · FX Shoulder Solutions, Inc. · May 2026
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · Smith & Nephew, Inc. · Oct 2025
INHANCE INTACT™
K243248 · Depuy Ireland UC · Dec 2024
OsseoFit Stemless Shoulder System
K241873 · Zimmer, Inc. · Dec 2024
AETOS Shoulder System Stemless Humeral Prosthesis
K240716 · Smith & Nephew, Inc. · Nov 2024
Tornier Perform Humeral System – Stemless
K220418 · Tornier, Inc. · Sep 2022