SMR Shoulder System
FDA 510(k) K161476 · Lima Corporate S.P.A.
510(k) numberK161476
Submission
- Device name
- SMR Shoulder System
- Applicant
- Lima Corporate S.P.A.
Udine, IT - Received
- May 27, 2016
- Decision date
- June 24, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3650
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | Shoulder Innovations, Inc. | 09/08/2026SE |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | Exactech, Inc. | 12/01/2025SE |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional | Tornier, Inc. | 10/30/2025SE |
| K241944 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 03/10/2025SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | Shoulder Innovations, Inc. | 02/11/2025SE |
| K231657 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 02/16/2024SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | Biomet Orthopedics | 07/12/2023SE |
| K222482 | AGILON XO Shoulder SystemKWT · Traditional | Implantcast GmbH | 09/28/2022SE |
| K210899 | LINK Embrace Shoulder System- Anatomical ConfigurationKWT · Traditional | Waldemar Link GmbH & Co. KG | 06/21/2021SE |
| K191698 | TiN Coated Humeral HeadKWT · Traditional | Fx Shoulder USA, Inc. | 07/16/2020SE |
More from Fx Shoulder USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemPHX · Traditional | 01/22/2026SE |
| K251718 | ArTT Augments and Buttresses and Bone ScrewsLPH · Traditional | 08/29/2025SE |
| K243826 | SMR Reverse HP Shoulder SystemPHX · Traditional | 07/03/2025SE |
| K250980 | Physica System (Physica CR Porous Femoral components)MBH · Traditional | 05/22/2025SE |
| K243615 | Physica Porous Femoral ComponentsMBH · Special | 12/18/2024SE |
| K234011 | AMF TT ConesJWH · Special | 01/18/2024SE |
| K233712 | PRIMA Humeral System; PRIMA TT GlenoidMBF · Traditional | 01/11/2024SE |
| K231099 | SMR Hybrid Glenoid SystemMBF · Traditional | 12/21/2023SE |
| K231925 | MINIMA S SystemLZO · Special | 07/11/2023SE |
| K221758 | SMR Stemless AnatomicPKC · Traditional | 03/17/2023SE |
Questions and answers
When was SMR Shoulder System cleared by the FDA?
SMR Shoulder System (K161476) received a 510(k) decision of Substantially Equivalent on June 24, 2016, 28 days after the submission was received.
What is the product code of K161476?
The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.