Biopro Glenoid Component W/ Keel & W/ Posts
FDA 510(k) K001046 · Biopro, Inc.
510(k) numberK001046
Submission
- Device name
- Biopro Glenoid Component W/ Keel & W/ Posts
- Applicant
- Biopro, Inc.
Port Huron, MI, US - Received
- March 31, 2000
- Decision date
- June 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | Tornier, Inc. | 07/22/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | Smith & Nephew, Inc. | 04/06/2026SE |
| K252418 | Catalyst F1x Shoulder SystemKWS · Traditional | Catalyst Orthoscience, Inc. | 11/06/2025SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | Smith & Nephew, Inc. | 10/29/2025SE |
| K241292 | MyShoulder Planner (5.3SSWPL)KWS · Traditional | Medacta International S.A. | 01/30/2025SE |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 12/06/2024SE |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 09/10/2024SE |
| K230513 | Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional | Arthrex, Inc. | 09/26/2023SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | Encore Medical L.P. | 06/23/2023SE |
| K230572 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 06/07/2023SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163627 | Shotel Ankle Arthrodesis Nail SystemHSB · Traditional | 09/14/2017SE |
| K162674 | BioPro Foot Plating SystemsHRS · Traditional | 06/16/2017SE |
| K132510 | Biopro - Infinity Plate Anchor SystemHTN · Traditional | 10/24/2013SE |
| K130298 | Biopro Kwick-Wire Universal Screw SystemJDW · Traditional | 06/18/2013SE |
| K121973 | Biopro Hemi-Edge Toe SystemKWD · Traditional | 10/30/2012SE |
| K100761 | Biopro Polar HeadKWY · Traditional | 12/03/2010SE |
| K101030 | Modification to HBS Headless Bone ScrewHWC · Special | 06/03/2010SE |
| K090208 | Biopro Femoral HeadsJDI · Traditional | 05/22/2009SE |
| K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685HTY · Traditional | 03/18/2009SE |
| K082705 | Biopro Bipolar Head, Models 18130-18152KWY · Traditional | 12/15/2008SE |
Questions and answers
When was Biopro Glenoid Component W/ Keel & W/ Posts cleared by the FDA?
Biopro Glenoid Component W/ Keel & W/ Posts (K001046) received a 510(k) decision of Substantially Equivalent on June 8, 2000, 69 days after the submission was received.
What is the product code of K001046?
The FDA product code is KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3660.