GMK Sphere Extension
FDA 510(k) K140826 · Medacta International
510(k) numberK140826
Submission
- Device name
- GMK Sphere Extension
- Applicant
- Medacta International
Chicago, IL, US - Received
- April 1, 2014
- Decision date
- July 15, 2014
- 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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| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | 06/10/2026SE |
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| K160289 | MasterLoc StemLZO · Traditional | 05/20/2016SE |
| K153664 | M.U.S.T. Pedicle Screw SystemNKB · Special | 01/19/2016SE |
| K151531 | MasterLoc StemLZO · Traditional | 10/30/2015SE |
| K142744 | Mecta-C TiPEEKODP · Traditional | 05/07/2015SE |
| K143453 | Mpact Double Mobility SystemLPH · Traditional | 03/02/2015SE |
| K142069 | GMK ExtensionJWH · Traditional | 12/02/2014SE |
| K141988 | M.U.S.T Pedicle Screw SystemNKB · Special | 08/19/2014SE |
| K141044 | M.U.S.T. ExtensionNKB · Traditional | 08/18/2014SE |
Questions and answers
When was GMK Sphere Extension cleared by the FDA?
GMK Sphere Extension (K140826) received a 510(k) decision of Substantially Equivalent on July 15, 2014, 105 days after the submission was received.
What is the product code of K140826?
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.