SmartSPACE Shoulder System

FDA 510(k) K191247 · Techmah Medical, LLC

Substantially Equivalent

510(k) numberK191247

Submission

Device name
SmartSPACE Shoulder System
Applicant
Techmah Medical, LLC
Knoxville, TN, US
Received
May 9, 2019
Decision date
November 15, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3660
Specialty
Orthopedic
Implant
Yes

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K260721Tornier Perform Advanced GlenoidKWS · Traditional Tornier, Inc.07/22/2026SE
K254084AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional Smith & Nephew, Inc.04/06/2026SE
K252418Catalyst F1x Shoulder SystemKWS · Traditional Catalyst Orthoscience, Inc.11/06/2025SE
K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional Smith & Nephew, Inc.10/29/2025SE
K241292MyShoulder Planner (5.3SSWPL)KWS · Traditional Medacta International S.A.01/30/2025SE
K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional Stryker Corporation (Tornier, Inc.)12/06/2024SE
K241609Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional Stryker Corporation (Tornier, Inc.)09/10/2024SE
K230513Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional Arthrex, Inc.09/26/2023SE
K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersKWS · Abbreviated Encore Medical L.P.06/23/2023SE
K230572AETOS Shoulder SystemKWS · Traditional Smith & Nephew, Inc.06/07/2023SE

More from Smith & Nephew, Inc.

510(k)DeviceDecision
K202151Smart SPACE Shoulder SystemQHE · Traditional 02/03/2021SE
K202454Smart SPACE Shoulder SystemQHE · Traditional 12/28/2020SE

Questions and answers

When was SmartSPACE Shoulder System cleared by the FDA?

SmartSPACE Shoulder System (K191247) received a 510(k) decision of Substantially Equivalent on November 15, 2019, 190 days after the submission was received.

What is the product code of K191247?

The FDA product code is KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3660.