Symmetric Total Knee System
FDA 510(k) K203779 · Signal Medical Corporation
510(k) numberK203779
Submission
- Device name
- Symmetric Total Knee System
- Applicant
- Signal Medical Corporation
Marysville, MI, US - Received
- December 28, 2020
- Decision date
- June 10, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3565
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | Smith & Nephew, Inc. | 09/08/2026SE |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | Microport Orthopedics, Inc. | 08/21/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | Zimmer, Inc. | 05/28/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | Zimmer, Inc. | 03/09/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | Medacta International S.A. | 02/26/2026SE |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 02/18/2026SE |
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | Signature Orthopaedics Pty, Ltd. | 12/23/2025SE |
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | Ortho Development Corp. | 12/19/2025SE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | Maxx Orthopedics, Inc. | 10/31/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/24/2025SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
|---|---|---|
| K100370 | Symmetric Total Knee AgumentsJWH · Traditional | 03/07/2011SE |
| K080199 | Symmetric Total Knee SystemJWH · Traditional | 07/03/2008SE |
| K073674 | Bone Fixation Wire (Kirschner Wire)HTY · Traditional | 03/24/2008SE |
| K051510 | Signal Medical Corporation Beacon Knee SystemMBH · Traditional | 03/22/2006SE |
| K043289 | E-Z Frame External Surgical Support BootKTT · Traditional | 02/11/2005SE |
| K022382 | RHS Acetabular ComponentLPH · Traditional | 10/04/2002SE |
| K021063 | Great Toe ImplantKWD · Traditional | 07/01/2002SE |
| K981302 | SMC 28MM Ceramic Femoral HeadsLZO · Traditional | 06/25/1998SE |
| K971681 | SMC Femoral Hip ComponentJDI · Traditional | 12/04/1997SE |
| K971018 | SMC Acetabular ComponentLPH · Traditional | 10/24/1997SE |
Questions and answers
When was Symmetric Total Knee System cleared by the FDA?
Symmetric Total Knee System (K203779) received a 510(k) decision of Substantially Equivalent on June 10, 2021, 164 days after the submission was received.
What is the product code of K203779?
The FDA product code is MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3565.