Cleared Traditional

SmartSPACE Shoulder System (K191247) - FDA 510(k) Clearance

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

K191247 · Techmah Medical, LLC · Orthopedic device
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Nov 2019
Decision
190d
Days
Class 2
Risk

K191247 is an FDA 510(k) clearance for the SmartSPACE Shoulder System. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Techmah Medical, LLC (Knoxville, US). The FDA issued a Cleared decision on November 15, 2019 after a review of 190 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 Techmah Medical, LLC devices

Submission Details

510(k) Number K191247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2019
Decision Date November 15, 2019
Days to Decision 190 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
68d slower than avg
Panel avg: 122d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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

Medical Device Academy, Inc.
Mary Vater

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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 95
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K191247.
AltiVate® Anatomic Pegged Glenoid with Markers
K203026 · Encore Medical, L.P. · Dec 2020
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K202289 · Stryker GmbH · Dec 2020
Alliance Augmented Glenoid
K193180 · Zimmer, Inc. · Feb 2020
Alliance Glenoid
K191814 · Zimmer, Inc. · Oct 2019
Materialise Glenoid Positioning System
K190286 · Materialise NV · Jul 2019
AEQUALIS FLEX REVIVE Shoulder System
K191318 · Tornier, Inc. · Jun 2019