Cas Psi Knee System
FDA 510(k) K131409 · Orthosoft, Inc.
510(k) numberK131409
Submission
- Device name
- Cas Psi Knee System
- Applicant
- Orthosoft, Inc.
Montreal, CA - Received
- May 15, 2013
- Decision date
- September 13, 2013
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K100599 | Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…OLO · Traditional | 04/05/2010SE |
| K071929 | Navitrack System- Partial Hip Resurfacing UniversalHAW · Traditional | 09/19/2007SE |
| K071714 | Navitrack System - Os Unicondylar Knee Universal, Model# PRO-06003HAW · Special | 07/20/2007SE |
| K060336 | Navitrack System-Os Knee Universal, Model PRO-05002HAW · Special | 04/28/2006SE |
| K043536 | Navitrack System - S&N Image Free KneeHAW · Special | 01/14/2005SE |
| K041369 | Navitrack System - S&N Image Free Hip, Model PRO-03017HAW · Special | 06/22/2004SE |
| K032917 | Navitrack System - Total Hip Replacement Ct-FreeHAW · Special | 10/21/2003SE |
| K030827 | Navitrack System: Total Hip Replacement Ct-Free Cup, Model 900.204HAW · Traditional | 05/23/2003SE |
| K031156 | Navitrack System-Fluorospine, Model 900.005HAW · Special | 05/09/2003SE |
| K022364 | Navitrack System Total Hip Replacement,Model 900.200HAW · Traditional | 02/04/2003SE |
Questions and answers
When was Cas Psi Knee System cleared by the FDA?
Cas Psi Knee System (K131409) received a 510(k) decision of Substantially Equivalent on September 13, 2013, 121 days after the submission was received.
What is the product code of K131409?
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.