MectaLIF 3D Metal Anterior
FDA 510(k) K254202 · Medacta International S.A.
510(k) numberK254202
Submission
- Device name
- MectaLIF 3D Metal Anterior
- Applicant
- Medacta International S.A.
Castel San Pietro, CH - Received
- December 29, 2025
- Decision date
- May 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVD
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|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
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| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer SystemOVD · Traditional | Avalign Technologies, Inc. | 07/10/2025SE |
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| K250644 | MSS - Monobloc stemPHX · Traditional | 02/03/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | 01/28/2026SE |
| K252847 | NextAR Hip PlatformSBF · Traditional | 01/09/2026SE |
| K242603 | MyPAO SA guidesPBF · Traditional | 11/19/2025SE |
| K250338 | MSS - Humeral reverse liners extensionPHX · Traditional | 10/31/2025SE |
| K250450 | Coated hip implantsLZO · Traditional | 09/19/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | 09/12/2025SE |
Questions and answers
When was MectaLIF 3D Metal Anterior cleared by the FDA?
MectaLIF 3D Metal Anterior (K254202) received a 510(k) decision of Substantially Equivalent on May 5, 2026, 127 days after the submission was received.
What is the product code of K254202?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.