Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial
FDA 510(k) K120990 · Zimmer Trabecular Metal Technology
510(k) numberK120990
Submission
- Device name
- Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial
- Applicant
- Zimmer Trabecular Metal Technology
Parsippany, NJ, US - Received
- April 2, 2012
- Decision date
- June 29, 2012
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K133784 | Vista-S Device, Associated InstrumentationODP · Traditional | 07/07/2014SE |
| K123602 | TM Ardis Interbody System InserterMAX · Traditional | 03/01/2013SE |
| 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 |
| K103517 | Trabecular Metal Femoral Cone AugmentsMBH · Traditional | 02/15/2011SE |
| 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 |
| K070754 | Trabecular Metal Vertebral Body Replacement (VBR), Model# 06-115, 06-155MQP · Traditional | 08/31/2007SE |
Questions and answers
When was Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial cleared by the FDA?
Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial (K120990) received a 510(k) decision of Substantially Equivalent on June 29, 2012, 88 days after the submission was received.
What is the product code of K120990?
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.