Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate
FDA 510(k) K031183 · Centerpulse Orthopedics, Inc.
510(k) numberK031183
Submission
- Device name
- Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate
- Applicant
- Centerpulse Orthopedics, Inc.
Austin, TX, US - Received
- April 15, 2003
- Decision date
- July 14, 2003
- 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 |
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| K033943 | Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedKWA · Traditional | 10/18/2004SE |
| K033634 | Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedKWA · Traditional | 09/15/2004SE |
| K040947 | Durasul BipolarKWY · Traditional | 08/27/2004SE |
| K033810 | Natural-Knee II Unicompartmental Knee SystemHRY · Traditional | 03/05/2004SE |
| K033664 | Modification to Alloclassic Zweymuller SL Offset Femoral StemLZO · Special | 12/17/2003SE |
| K032348 | Converge Reti-Lock Multi-Hole Reinforcement CupLZO · Traditional | 10/24/2003SE |
| K030923 | Epsilon Durasul Constrained Acetabular LinerKWZ · Traditional | 10/03/2003SE |
| K032380 | Wagner Cone ProsthesisLZO · Traditional | 09/22/2003SE |
| K030373 | Alloclassic Zweymueller Sl/Sll Femoral StemLZO · Special | 03/06/2003SE |
Questions and answers
When was Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate cleared by the FDA?
Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate (K031183) received a 510(k) decision of Substantially Equivalent on July 14, 2003, 90 days after the submission was received.
What is the product code of K031183?
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.