Univers Revers CA Head and Adapter
FDA 510(k) K233260 · Arthrex, Inc.
510(k) numberK233260
Submission
- Device name
- Univers Revers CA Head and Adapter
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- September 29, 2023
- Decision date
- February 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3690
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221232 | Univers Revers Humeral Cup ImplantHSD · Special | Arthrex, Inc. | 05/19/2022SE |
| K191433 | AGILON® XO Shoulder Replacement SystemHSD · Traditional | Implantcast GmbH | 11/12/2020SE |
| K193122 | Biocore9 Humeral Resurfacing SystemHSD · Traditional | Biocore9, LLC | 05/15/2020SE |
| K173964 | OVOMotion Shoulder Arthroplasty SystemHSD · Traditional | Arthrosurface, Inc. | 04/18/2018SE |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional | Arthrex, Inc. | 11/21/2016SE |
| K161620 | Anatomical Shoulder Domelock Dome centricHSD · Traditional | Zimmer GmbH | 11/01/2016SE |
| K151527 | Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional | Arthrex, Inc. | 04/19/2016SE |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD · Special | Arthrosurface, Inc. | 12/19/2014SE |
| K131298 | Exactech Equinoxe Resurfacing Humeral Head SystemHSD · Traditional | Exactech, Inc. | 11/26/2013SE |
| K130759 | Humelock II Cementless Shoulder SystemHSD · Traditional | Fx Solutions | 11/09/2013SE |
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Questions and answers
When was Univers Revers CA Head and Adapter cleared by the FDA?
Univers Revers CA Head and Adapter (K233260) received a 510(k) decision of Substantially Equivalent on February 12, 2024, 136 days after the submission was received.
What is the product code of K233260?
The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.