Trabecular Metal Femoral Cone Augments
FDA 510(k) K103517 · Zimmer Trabecular Metal Technology, Inc.
510(k) numberK103517
Submission
- Device name
- Trabecular Metal Femoral Cone Augments
- Applicant
- Zimmer Trabecular Metal Technology, Inc.
Parsippany, NJ, US - Received
- November 30, 2010
- Decision date
- February 15, 2011
- 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
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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 |
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| K120990 | Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK…MBH · Traditional | 06/29/2012SE |
| K120203 | TM-400 DeviceMAX · Traditional | 06/15/2012SE |
| K113561 | TM Ardis Interbody System TM Ardis Interbody System InstrumenationMAX · Traditional | 05/29/2012SE |
| K111983 | Vista-S Device Model 08/06-401-XXXXX, 08/06-402-XXXXXXODP · Traditional | 11/18/2011SE |
| K103033 | Trabecular Metal Fusion Device Model 06-101-XXXXX, 06-102-XXXXX and 08-100-XXXXXODP · Traditional | 01/10/2011SE |
| K102896 | Trabecular Metal Tibial Cone AugmentsMBH · Traditional | 12/13/2010SE |
| K093127 | Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument SetMQP · Traditional | 03/04/2010SE |
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Questions and answers
When was Trabecular Metal Femoral Cone Augments cleared by the FDA?
Trabecular Metal Femoral Cone Augments (K103517) received a 510(k) decision of Substantially Equivalent on February 15, 2011, 77 days after the submission was received.
What is the product code of K103517?
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.