Freedom® Medial Congruent Liner
FDA 510(k) K243277 · Maxx Orthopedics, Inc.
510(k) numberK243277
Submission
- Device name
- Freedom® Medial Congruent Liner
- Applicant
- Maxx Orthopedics, Inc.
Norristown, PA, US - Received
- October 16, 2024
- Decision date
- November 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
More from NovoSource
| 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 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | 10/31/2025SE |
| 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 |
Questions and answers
When was Freedom® Medial Congruent Liner cleared by the FDA?
Freedom® Medial Congruent Liner (K243277) received a 510(k) decision of Substantially Equivalent on November 19, 2024, 34 days after the submission was received.
What is the product code of K243277?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.