SMR Stemless Anatomic
FDA 510(k) K221758 · Lima Corporate S.P.A.
510(k) numberK221758
Submission
- Device name
- SMR Stemless Anatomic
- Applicant
- Lima Corporate S.P.A.
Villanova Di San Daniele Del Friuli, IT - Received
- June 16, 2022
- Decision date
- March 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PKC – Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Replacement of the humeral head for total anatomic shoulder arthroplasty
Other 510(k)s with product code PKC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254154 | FX V135 EASYTECH® Shoulder SystemPKC · Traditional | FX Shoulder Solutions, Inc. | 05/01/2026SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | Smith & Nephew, Inc. | 10/03/2025SE |
| K243248 | Inhance IntactPKC · Traditional | Depuy Ireland UC | 12/23/2024SE |
| K241873 | OsseoFit Stemless Shoulder SystemPKC · Traditional | Zimmer, Inc. | 12/11/2024SE |
| K240716 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | Smith & Nephew, Inc. | 11/20/2024SE |
| K220418 | Tornier Perform Humeral System StemlessPKC · Traditional | Tornier, Inc. | 09/14/2022SE |
| K213615 | Shoulder Innovations Total Shoulder SystemPKC · Traditional | Shoulder Innovations, Inc. | 03/11/2022SE |
| K212683 | GLOBAL ICON Stemless Shoulder SystemPKC · Traditional | Depuy(Ireland) | 01/19/2022SE |
| K203108 | Ignite Stemless Anatomic Shoulder SystemPKC · Traditional | Ignite Orthopedics, LLC | 07/16/2021SE |
| K201391 | Easytech® Anatomical Shoulder SystemPKC · Traditional | Fx Shoulder USA, Inc. | 02/16/2021SE |
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 |
| K223876 | SMR Shoulder SystemMBF · Traditional | 02/03/2023SE |
Questions and answers
When was SMR Stemless Anatomic cleared by the FDA?
SMR Stemless Anatomic (K221758) received a 510(k) decision of Substantially Equivalent on March 17, 2023, 274 days after the submission was received.
What is the product code of K221758?
The FDA product code is PKC – Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3660.