AETOS Shoulder System Stemless Humeral Prosthesis
FDA 510(k) K240716 · Smith & Nephew, Inc.
510(k) numberK240716
Submission
- Device name
- AETOS Shoulder System Stemless Humeral Prosthesis
- Applicant
- Smith & Nephew, Inc.
Cordova, TN, US - Received
- March 15, 2024
- Decision date
- November 20, 2024
- 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 |
| K221758 | SMR Stemless AnatomicPKC · Traditional | Lima Corporate S.P.A. | 03/17/2023SE |
| 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 |
|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | 09/08/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | 07/09/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | 04/06/2026SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | 10/29/2025SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 10/03/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
| K250571 | CATALYSTEM Femoral StemsLZO · Special | 03/28/2025SE |
| K241666 | EVOS Pelvic and Acetabular SystemHRS · Traditional | 02/19/2025SE |
Questions and answers
When was AETOS Shoulder System Stemless Humeral Prosthesis cleared by the FDA?
AETOS Shoulder System Stemless Humeral Prosthesis (K240716) received a 510(k) decision of Substantially Equivalent on November 20, 2024, 250 days after the submission was received.
What is the product code of K240716?
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.