Remedy® Shoulder Spacer
FDA 510(k) K152267 · Osteoremedies, LLC
510(k) numberK152267
Submission
- Device name
- Remedy® Shoulder Spacer
- Applicant
- Osteoremedies, LLC
Memphis, TN, US - Received
- August 11, 2015
- Decision date
- December 15, 2015
- 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 |
|---|---|---|
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular CupKWL · Special | 07/24/2026SE |
| K253675 | OsteoRemedies Hip Spacer SystemKWL · Special | 12/23/2025SE |
| K250760 | SPECTRUM GV Bone CementLOD · Special | 04/02/2025SE |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentJWH · Traditional | 10/02/2024SE |
| K231556 | SPECTRUM® GV Bone CementLOD · Traditional | 12/20/2023SE |
| K223650 | REMEDY Stemmed Knee SpacerJWH · Special | 01/05/2023SE |
| K192995 | OsteoRemedies Hip Spacer SystemKWL · Special | 01/10/2020SE |
| K191981 | REMEDY Acetabular CupKWL · Special | 08/23/2019SE |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerJWH · Traditional | 07/25/2019SE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL · Traditional | 08/29/2018SE |
Questions and answers
When was Remedy® Shoulder Spacer cleared by the FDA?
Remedy® Shoulder Spacer (K152267) received a 510(k) decision of Substantially Equivalent on December 15, 2015, 126 days after the submission was received.
What is the product code of K152267?
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.