MLP Special Locking Bone Plate System
by Maxxion Medical, LLC / Baumer SA
510(k) K181843
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181843 | Date4 Mar 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The MLP Special Locking Bone Plate System is a metallic bone fixation appliance designed for internal fixation of long bones and joints. It is classified under Single/Multiple Component Metallic Bone Fixation Appliances (21 CFR 888.3030) and features locking mechanisms for secure stabilization of fractures, fusions, osteotomies, pseudoarthroses, and non-unions in pediatric and adult populations.
This system is supplied sterile and intended for single-use, though reuse may be considered under controlled conditions. It is compatible with MRI environments and available in various sizes to accommodate different anatomical sites, including the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal, and metatarsophalangeal regions. Authorized for use in the United States under FDA 510(k) clearance (K181843), it adheres to traditional review standards for orthopedic devices.
Questions
AI-generated answers, 19 Sep 2026
What types of bone injuries or conditions is the MLP Special Locking Bone Plate System designed to stabilize, and does it work for both adults and children?
The MLP Special Locking Bone Plate System is designed for internal fixation of fractures, fusions, osteotomies, pseudoarthroses, and non-unions. It is explicitly noted to be suitable for both pediatric and adult populations, providing secure stabilization through its locking mechanisms for long bones and joints across various anatomical sites.
Is the MLP Special Locking Bone Plate System intended for reuse, or is it meant to be used only once?
The system is supplied sterile and intended for single-use. However, reuse may be considered under controlled conditions, meaning it can be used again if proper protocols and sterilization procedures are followed, though this is not the standard recommendation.
What anatomical regions can the MLP Special Locking Bone Plate System be used for, and how does the system accommodate different sizes?
The system is available in various sizes to fit multiple anatomical sites, including the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal, and metatarsophalangeal regions. This versatility allows clinicians to select the appropriate size for the specific bone or joint being treated.
Can the MLP Special Locking Bone Plate System be used in MRI environments, and why might this be important for patients?
Yes, the MLP Special Locking Bone Plate System is compatible with MRI environments. This is important because it allows patients who undergo fixation with this system to safely undergo MRI scans later, which can be critical for diagnosing or monitoring conditions that require imaging without radiation exposure.
How was the FDA clearance for the MLP Special Locking Bone Plate System determined, and what does this mean for its regulatory status?
The MLP Special Locking Bone Plate System received FDA clearance under the 510(k) pathway with a decision code of 'SESE' (Substantially Equivalent in Safety and Effectiveness) through the Orthopedic (OR) advisory committee. This means the FDA determined it is substantially equivalent to a legally marketed predicate device, adhering to traditional review standards for orthopedic devices.