Humeral Short Stem System
FDA 510(k) K173824 · Shoulder Innovations, Inc.
510(k) numberK173824
Submission
- Device name
- Humeral Short Stem System
- Applicant
- Shoulder Innovations, Inc.
Holland, MI, US - Received
- December 18, 2017
- Decision date
- October 23, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3670
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional | Zimmer, Inc. | 04/13/2026SE |
| K251098 | Identity Revision Humeral StemsMBF · Traditional | Zimmer, Inc. | 08/11/2025SE |
| K250848 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 07/02/2025SE |
| K240876 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 06/12/2024SE |
| K233712 | PRIMA Humeral System; PRIMA TT GlenoidMBF · Traditional | Lima Corporate S.P.A. | 01/11/2024SE |
| K231099 | SMR Hybrid Glenoid SystemMBF · Traditional | Lima Corporate S.P.A. | 12/21/2023SE |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidMBF · Traditional | Depuy Ireland UC | 11/13/2023SE |
| K231516 | INHANCE Shoulder System, Sterile Single Use InstrumentationMBF · Traditional | Depuy Ireland UC | 07/21/2023SE |
| K223876 | SMR Shoulder SystemMBF · Traditional | Lima Corporate S.P.A. | 02/03/2023SE |
| K222427 | PRIMA TT GlenoidMBF · Traditional | Lima Corporate S.P.A. | 10/06/2022SE |
More from Lima Corporate S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | 09/08/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | 04/13/2026SE |
| K252516 | N22 EZ GlenospherePHX · Traditional | 01/15/2026SE |
| K252221 | Inset Reverse Total Shoulder SystemPHX · Traditional | 09/26/2025SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | 02/11/2025SE |
| K213615 | Shoulder Innovations Total Shoulder SystemPKC · Traditional | 03/11/2022SE |
| K210533 | Inset Reverse Total Shoulder SystemPHX · Traditional | 08/20/2021SE |
| K192365 | Shoulder Innovations Total Shoulder SystemKWT · Special | 11/29/2019SE |
| K111596 | Total Shoulder SystemKWS · Special | 07/05/2011SE |
| K110905 | Total Shoulder SystemKWS · Special | 05/24/2011SE |
Questions and answers
When was Humeral Short Stem System cleared by the FDA?
Humeral Short Stem System (K173824) received a 510(k) decision of Substantially Equivalent on October 23, 2018, 309 days after the submission was received.
What is the product code of K173824?
The FDA product code is MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3670.