Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Pla
FDA 510(k) K133162 · Materialise NV
510(k) numberK133162
Submission
- Device name
- Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Pla
- Applicant
- Materialise NV
Leuven, BE - Received
- October 17, 2013
- Decision date
- February 25, 2014
- 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 |
|---|---|---|
| K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | 06/09/2026SE |
| K251964 | Mimics Thoracic PlannerLLZ · Traditional | 03/12/2026SE |
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…PPT · Special | 01/07/2026SE |
| K253793 | Materialise TKA Guide SystemJWH · Special | 01/06/2026SE |
| K251554 | Materialise TKA Guide SystemJWH · Traditional | 07/14/2025SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | 02/21/2025SE |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 10/18/2024SE |
| K223427 | Mimics Enlight CMFLLZ · Traditional | 05/31/2024SE |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 05/22/2024SE |
| K233217 | Mimics Cardiac PlannerLLZ · Traditional | 02/12/2024SE |
Questions and answers
When was Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Pla cleared by the FDA?
Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Pla (K133162) received a 510(k) decision of Substantially Equivalent on February 25, 2014, 131 days after the submission was received.
What is the product code of K133162?
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.