Arthrex iBalance TKA System
FDA 510(k) K153586 · Arthrex, Inc.
510(k) numberK153586
Submission
- Device name
- Arthrex iBalance TKA System
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- December 16, 2015
- Decision date
- February 19, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3565
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBH
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|---|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | Smith & Nephew, Inc. | 09/08/2026SE |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | Microport Orthopedics, Inc. | 08/21/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | Zimmer, Inc. | 05/28/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | Zimmer, Inc. | 03/09/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | Medacta International S.A. | 02/26/2026SE |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 02/18/2026SE |
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | Signature Orthopaedics Pty, Ltd. | 12/23/2025SE |
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | Ortho Development Corp. | 12/19/2025SE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | Maxx Orthopedics, Inc. | 10/31/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/24/2025SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
|---|---|---|
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| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | 08/07/2026SE |
| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | 07/30/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | 06/26/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | 06/25/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | 05/28/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | 03/20/2026SE |
| K260405 | FiberTape ButtonMBI · Special | 03/09/2026SE |
Questions and answers
When was Arthrex iBalance TKA System cleared by the FDA?
Arthrex iBalance TKA System (K153586) received a 510(k) decision of Substantially Equivalent on February 19, 2016, 65 days after the submission was received.
What is the product code of K153586?
The FDA product code is MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3565.