3-PIECE Proximal Humeral Replacement System
FDA 510(k) K020045 · Biomet Orthopedics, Inc.
510(k) numberK020045
Submission
- Device name
- 3-PIECE Proximal Humeral Replacement System
- Applicant
- Biomet Orthopedics, Inc.
Warsaw, IN, US - Received
- January 7, 2002
- Decision date
- January 30, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | 08/24/2026SE |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | 04/15/2026SE |
| K243761 | A.L.P.S. Small Fragment Plating SystemHRS · Traditional | 02/19/2025SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | 07/12/2023SE |
| K200196 | Taperloc® Complete Hip StemsLZO · Traditional | 12/08/2020SE |
| K131393 | Mak Oss Femoral Knee ComponentsKRO · Traditional | 10/24/2013SE |
| K112905 | Compress(R) Segmental Humeral Replacement SystemMBF · Traditional | 05/24/2012SE |
| K080528 | E-Poly Tibial BearingsJWH · Traditional | 06/17/2008SE |
| K072879 | Innervue Diagnostic Scope SystemHRX · Traditional | 01/14/2008SE |
| K070955 | Acid Etched Lag ScrewsHSB · Traditional | 10/12/2007SE |
Questions and answers
When was 3-PIECE Proximal Humeral Replacement System cleared by the FDA?
3-PIECE Proximal Humeral Replacement System (K020045) received a 510(k) decision of Substantially Equivalent on January 30, 2002, 23 days after the submission was received.
What is the product code of K020045?
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.