Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model 1.1 (4.3.0.35)
FDA 510(k) K091263 · Materialise NV
510(k) numberK091263
Submission
- Device name
- Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model 1.1 (4.3.0.35)
- Applicant
- Materialise NV
Leuven, BE - Received
- April 30, 2009
- Decision date
- November 19, 2009
- 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 |
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| K251554 | Materialise TKA Guide SystemJWH · Traditional | 07/14/2025SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | 02/21/2025SE |
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Questions and answers
When was Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model 1.1 (4.3.0.35) cleared by the FDA?
Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model 1.1 (4.3.0.35) (K091263) received a 510(k) decision of Substantially Equivalent on November 19, 2009, 203 days after the submission was received.
What is the product code of K091263?
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.