Arthrex Eclipse Titanium Humeral Head
FDA 510(k) K203100 · Arthrex, Inc.
510(k) numberK203100
Submission
- Device name
- Arthrex Eclipse Titanium Humeral Head
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- October 14, 2020
- Decision date
- November 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
More from Ignite Orthopedics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | 09/01/2026SE |
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | 08/07/2026SE |
| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | 07/30/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | 06/26/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | 06/25/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | 05/28/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | 03/20/2026SE |
| K260405 | FiberTape ButtonMBI · Special | 03/09/2026SE |
Questions and answers
When was Arthrex Eclipse Titanium Humeral Head cleared by the FDA?
Arthrex Eclipse Titanium Humeral Head (K203100) received a 510(k) decision of Substantially Equivalent on November 20, 2020, 37 days after the submission was received.
What is the product code of K203100?
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.