VEGA Knee System, Columbus Total Knee System

Q: What is the product code of K143443?

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.

FDA 510(k) K143443 · Aesculap Implants Systems, LLC

Substantially Equivalent

510(k) numberK143443

Submission

Device name: VEGA Knee System, Columbus Total Knee System
Applicant: Aesculap Implants Systems, LLC
Center Valley, PA, US
Received: December 2, 2014
Decision date: March 25, 2015
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

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
K231769	activL® Next Generation InstrumentationQLQ · Special	07/13/2023SE
K172235	CoreHip® SystemLZO · Traditional	03/28/2018SE
K172032	Modulift Vertebral Body Replacement (VBR) SystemPLR · Traditional	11/20/2017SE

Questions and answers

When was VEGA Knee System, Columbus Total Knee System cleared by the FDA?

VEGA Knee System, Columbus Total Knee System (K143443) received a 510(k) decision of Substantially Equivalent on March 25, 2015, 113 days after the submission was received.

What is the product code of K143443?

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.