Rotaglide + Modular Knee System with Fixed Meniscus
FDA 510(k) K000232 · Corin USA
510(k) numberK000232
Submission
- Device name
- Rotaglide + Modular Knee System with Fixed Meniscus
- Applicant
- Corin USA
Tampa, FL, US - Received
- January 27, 2000
- Decision date
- February 25, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K203751 | OMNIVision systemOLO · Traditional | 04/12/2021SE |
| K202805 | Optimized Positioning System (OPS) InsightLLZ · Traditional | 11/20/2020SE |
| K193545 | Corin Optimized Positioning System (OPS) FemoralLZO · Traditional | 08/04/2020SE |
| K193042 | Optimized Positioning System (OPS) ReViewLLZ · Traditional | 06/26/2020SE |
| K192656 | Optimized Positioning System (OPS) InsightLLZ · Traditional | 05/01/2020SE |
| K190143 | LARS AC Band DeviceHTN · Traditional | 11/04/2019SE |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA)LZO · Traditional | 07/22/2019SE |
| K183038 | Corin Optimized Positioning System (OPS) PlanLLZ · Traditional | 11/26/2018SE |
| K181061 | Corin Optimized Positioning System (OPS) FemoralLZO · Traditional | 09/07/2018SE |
| K152893 | Corin Optimized Positioning System (OPS)LZO · Traditional | 06/03/2016SE |
Questions and answers
When was Rotaglide + Modular Knee System with Fixed Meniscus cleared by the FDA?
Rotaglide + Modular Knee System with Fixed Meniscus (K000232) received a 510(k) decision of Substantially Equivalent on February 25, 2000, 29 days after the submission was received.
What is the product code of K000232?
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.