Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
FDA 510(k) K252777 · Maxx Orthopedics, Inc.
510(k) numberK252777
Submission
- Device name
- Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
- Applicant
- Maxx Orthopedics, Inc.
Norristown, PA, US - Received
- September 2, 2025
- Decision date
- October 31, 2025
- 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 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/24/2025SE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ PatellaMBH · Traditional | United Orthopedic Corporation | 07/31/2025SE |
More from United Orthopedic Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | 08/07/2026SE |
| K261609 | Freedom Partial Knee SystemHSX · Traditional | 08/04/2026SE |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional | 01/15/2026SE |
| K253314 | Freedom Infinia Total Knee SystemJWH · Special | 10/29/2025SE |
| K253144 | Freedom® Total Knee System Titan PCK ComponentsJWH · Special | 10/22/2025SE |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip)KWY · Traditional | 08/25/2025SE |
| K251717 | Freedom® Total Knee System Titanium Tibial Base PlateJWH · Special | 06/26/2025SE |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate)JWH · Special | 03/13/2025SE |
| K241597 | Freedom® Total Knee System - Porous Tibial Base PlateMBH · Traditional | 02/13/2025SE |
| K243277 | Freedom® Medial Congruent LinerJWH · Special | 11/19/2024SE |
Questions and answers
When was Freedom Metaphyseal Cone Implants (Metaphyseal Cones) cleared by the FDA?
Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (K252777) received a 510(k) decision of Substantially Equivalent on October 31, 2025, 59 days after the submission was received.
What is the product code of K252777?
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.