COPAL knee moulds
FDA 510(k) K222570 · Heraeus Medical GmbH
510(k) numberK222570
Submission
- Device name
- COPAL knee moulds
- Applicant
- Heraeus Medical GmbH
Wehrheim, DE - Received
- August 23, 2022
- Decision date
- February 4, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K241674 | Osteopal® VLOD · Traditional | 12/05/2024SE |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+VKWL · Traditional | 02/15/2024SE |
| K220492 | COPAL exchange G hip spacerKWY · Special | 03/23/2022SE |
| K213812 | PALACOS MV proLOD · Traditional | 02/02/2022SE |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD · Traditional | 07/09/2021SE |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GLOD · Traditional | 11/23/2020SE |
| K191016 | COPAL exchange G Hip and Knee SpacersKWY · Traditional | 11/01/2019SE |
| K190766 | PALACOS fast R+GLOD · Traditional | 05/31/2019SE |
| K182260 | Palacos MVLOD · Special | 09/17/2018SE |
| K153737 | OSTEOPAL plusLOD · Special | 04/22/2016SE |
Questions and answers
When was COPAL knee moulds cleared by the FDA?
COPAL knee moulds (K222570) received a 510(k) decision of Substantially Equivalent on February 4, 2023, 165 days after the submission was received.
What is the product code of K222570?
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.