Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
FDA 510(k) K150544 · Aesculap Implant Systems, LLC
510(k) numberK150544
Submission
- Device name
- Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
- Applicant
- Aesculap Implant Systems, LLC
Center Valley, PA, US - Received
- March 3, 2015
- Decision date
- May 29, 2015
- 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 |
| K141694 | Aesculap Orthopilot Next GenerationOLO · Special | 02/24/2015SE |
Questions and answers
When was Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System cleared by the FDA?
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System (K150544) received a 510(k) decision of Substantially Equivalent on May 29, 2015, 87 days after the submission was received.
What is the product code of K150544?
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.