SMR Shoulder System- Revision Stems
FDA 510(k) K111212 · Lima Corporate S.P.A.
510(k) numberK111212
Submission
- Device name
- SMR Shoulder System- Revision Stems
- Applicant
- Lima Corporate S.P.A.
Winona Lake, IN, US - Received
- April 29, 2011
- Decision date
- July 28, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
Other 510(k)s with product code KWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | Tornier, Inc. | 07/22/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | Smith & Nephew, Inc. | 04/06/2026SE |
| K252418 | Catalyst F1x Shoulder SystemKWS · Traditional | Catalyst Orthoscience, Inc. | 11/06/2025SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | Smith & Nephew, Inc. | 10/29/2025SE |
| K241292 | MyShoulder Planner (5.3SSWPL)KWS · Traditional | Medacta International S.A. | 01/30/2025SE |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 12/06/2024SE |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 09/10/2024SE |
| K230513 | Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional | Arthrex, Inc. | 09/26/2023SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | Encore Medical L.P. | 06/23/2023SE |
| K230572 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 06/07/2023SE |
More from Smith & Nephew, 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- Revision Stems cleared by the FDA?
SMR Shoulder System- Revision Stems (K111212) received a 510(k) decision of Substantially Equivalent on July 28, 2011, 90 days after the submission was received.
What is the product code of K111212?
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.