FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
K Number: K241034
·
Decision Jun 12, 2024
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
18
Applicant Total
165
Review Days
57
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
- K Number
- K241034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International S.A.
- Date Received
- April 16, 2024
- Decision Date
- June 12, 2024
- Product Code
- PML
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PML | Bone Cement, Posterior Screw Augmentation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PML), ordered by most recent decision date.
Dynamo Spinal Cement; Salvo® Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
PERLA® TL System; TEKTONA® HV US Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
VADER® Pedicle System, G21 Cement
FDA 510(k)
FDA Class 2
·Orthopedic
Invictus® Bone Cement, Invictus Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Medacta International S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K254202 | MectaLIF 3D Metal Anterior | May 5, 2026 | Substantially Equivalent |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Apr 28, 2026 | Substantially Equivalent |
| K253328 | GMK 3D Metal Tibial Tray Extension | Feb 26, 2026 | Substantially Equivalent |
| K250644 | MSS - Monobloc stem | Feb 3, 2026 | Substantially Equivalent |
| K251043 | Mpact 3D Metal Implants Extension DMLS Technology | Jan 28, 2026 | Substantially Equivalent |
| K252847 | NextAR Hip Platform | Jan 9, 2026 | Substantially Equivalent |
| K242603 | MyPAO SA guides | Nov 19, 2025 | Substantially Equivalent |
| K250338 | MSS - Humeral reverse liners extension | Oct 31, 2025 | Substantially Equivalent |
| K250450 | Coated hip implants | Sep 19, 2025 | Substantially Equivalent |
| K252225 | PowerKnot High Strength Sutures | Sep 12, 2025 | Substantially Equivalent |