Neer Type Shoulder Prosthesis System
FDA 510(k) K922865 · Osteo Technology, Inc.
510(k) numberK922865
Submission
- Device name
- Neer Type Shoulder Prosthesis System
- Applicant
- Osteo Technology, Inc.
Timonium, MD, US - Received
- June 4, 1992
- Decision date
- December 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3650
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | Shoulder Innovations, Inc. | 09/08/2026SE |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | Exactech, Inc. | 12/01/2025SE |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional | Tornier, Inc. | 10/30/2025SE |
| K241944 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 03/10/2025SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | Shoulder Innovations, Inc. | 02/11/2025SE |
| K231657 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 02/16/2024SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | Biomet Orthopedics | 07/12/2023SE |
| K222482 | AGILON XO Shoulder SystemKWT · Traditional | Implantcast GmbH | 09/28/2022SE |
| K210899 | LINK Embrace Shoulder System- Anatomical ConfigurationKWT · Traditional | Waldemar Link GmbH & Co. KG | 06/21/2021SE |
| K191698 | TiN Coated Humeral HeadKWT · Traditional | Fx Shoulder USA, Inc. | 07/16/2020SE |
More from Fx Shoulder USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K926156 | Replica(Tm) Total Hip SystemLPH · Traditional | 03/09/1994SN |
| K922859 | Anatomical Type Knee SystemJWH · Traditional | 09/23/1993SE |
| K922869 | Total Condylat Type Knee SystemJWH · Traditional | 07/13/1993SE |
| K925447 | Oti Orthopedic Wire SystemJDQ · Traditional | 06/29/1993SE |
| K926213 | Modified Zickel Intramedullary Rod SystemHSB · Traditional | 06/17/1993SE |
| K922861 | Biometric Screw Fixation CupJDL · Traditional | 05/12/1993SE |
| K922870 | Three Spike CupGRF · Traditional | 04/08/1993SE |
| K925301 | Oti Orthopedic Fastener SystemHTY · Traditional | 03/16/1993SE |
| K922682 | Americana Hip ProthesisJDG · Traditional | 03/16/1993SE |
| K922871 | Unifit Femoral StemJDI · Traditional | 02/12/1993SE |
Questions and answers
When was Neer Type Shoulder Prosthesis System cleared by the FDA?
Neer Type Shoulder Prosthesis System (K922865) received a 510(k) decision of Substantially Equivalent on December 10, 1992, 189 days after the submission was received.
What is the product code of K922865?
The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.