Natural-Knee II System Cocr Tibial Baseplate
FDA 510(k) K021578 · Sulzer Orthopedics, Inc.
510(k) numberK021578
Submission
- Device name
- Natural-Knee II System Cocr Tibial Baseplate
- Applicant
- Sulzer Orthopedics, Inc.
Austin, TX, US - Received
- May 14, 2002
- Decision date
- August 9, 2002
- 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 |
|---|---|---|
| K022985 | Ascendent Acetabular SystemLZO · Traditional | 12/05/2002SE |
| K020713 | MS-30 Lateral Femoral StemLZO · Traditional | 05/14/2002SE |
| K013935 | Allofit Acetabular System 32MM Alpha Durasul InsertsLZO · Special | 12/13/2001SE |
| K013031 | Most Options SystemKRO · Traditional | 12/07/2001SE |
| K012739 | Converge Acetabular SystemLPH · Traditional | 11/14/2001SE |
| K012961 | Sulzer Orthopedics Converge Acetabular SystemJDI · Special | 10/18/2001SE |
| K011954 | Sulzer Orthopedics Allegretto Unicompartmental KneeHSX · Traditional | 09/19/2001SE |
| K010839 | CLS Varus Stem/Cls 135 StemLZO · Special | 04/18/2001SE |
| K003758 | Allofit Acetabular SystemKWA · Traditional | 03/07/2001SE |
| K003801 | Anatomical Press-Fit Humeral StemKWS · Traditional | 02/28/2001SE |
Questions and answers
When was Natural-Knee II System Cocr Tibial Baseplate cleared by the FDA?
Natural-Knee II System Cocr Tibial Baseplate (K021578) received a 510(k) decision of Substantially Equivalent on August 9, 2002, 87 days after the submission was received.
What is the product code of K021578?
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.