Vega Knee System
FDA 510(k) K140452 · Aesculap Implant Systems
510(k) numberK140452
Submission
- Device name
- Vega Knee System
- Applicant
- Aesculap Implant Systems
Center Valley, PA, US - Received
- February 24, 2014
- Decision date
- March 25, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K213871 | Ennovate Cervical Spinal and Occiput SystemNKG · Traditional | 07/01/2022SE |
| K210963 | ENNOVATE Spinal SystemNKB · Traditional | 07/19/2021SE |
| K180433 | Ennovate®NKB · Traditional | 04/26/2018SE |
| K162134 | ENNOVATE Spinal SystemNKB · Traditional | 12/14/2016SE |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsOLO · Traditional | 07/08/2016SE |
| K153629 | ArcadiusXP C Spinal SystemOVE · Traditional | 05/25/2016SE |
| K153396 | Aesculap OrthoPilot Next GenerationOLO · Traditional | 05/16/2016SE |
| K151938 | S4 Cervical Spinal and Occiput SystemsNKG · Traditional | 10/21/2015SE |
| K151056 | Aesculap T-Space PEEK and XP Spinal SystemMAX · Traditional | 08/13/2015SE |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee SystemJWH · Special | 05/29/2015SE |
Questions and answers
When was Vega Knee System cleared by the FDA?
Vega Knee System (K140452) received a 510(k) decision of Substantially Equivalent on March 25, 2014, 29 days after the submission was received.
What is the product code of K140452?
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.