Level One Hand Plating System
510(k) K170124
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170124 | Date9 Mar 2017 | 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- Withdrawn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
- FDA applicant
- KLS Martin L.P.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Level One Hand Plating System is a titanium-based orthopedic fixation device designed for osteosynthesis in hand surgery. It consists of modular plates and screws intended for internal fixation of fractures, providing stable support to promote proper bone alignment and healing. The system is categorized under orthopedic hardware for hand applications, offering solutions for complex fracture management in this anatomical region.
This system is supplied as a reusable set of modular components, including plates and color-coded screw packs, allowing customization for specific surgical requirements. It is intended for use in sterile operating room environments by qualified surgeons. The device is regulated under FDA 510(k) clearance (K170124) and is classified under the product code HRS for orthopedic hand fixation. No specific MRI safety or single-use designation is noted in the available data.
Other devices from KLS-Martin L.P.
Questions
AI-generated answers, 1 Oct 2026
What is the Level One Hand Plating System used for?
The Level One Hand Plating System is designed specifically for internal fixation of fractures in hand surgery. It provides stable support to help align and heal broken bones by using modular titanium plates and screws. This system is particularly useful for managing complex fractures in the hand, where precise alignment and secure fixation are critical for optimal recovery.
Is the Level One Hand Plating System reusable or single-use?
The Level One Hand Plating System is supplied as a reusable set of modular components. This includes plates and color-coded screw packs, allowing surgeons to customize the system for specific surgical needs. Reusability helps reduce costs and waste while maintaining sterility through proper cleaning and sterilization protocols in the operating room environment.
What materials are used in the Level One Hand Plating System?
The Level One Hand Plating System is made from titanium-based materials. Titanium is commonly used in orthopedic fixation devices due to its strength, lightweight properties, and biocompatibility, which reduce the risk of adverse reactions in the body during healing.
How is the Level One Hand Plating System regulated?
The Level One Hand Plating System has received FDA 510(k) clearance under the reference number K170124. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and meets regulatory standards for safety and effectiveness. The system is classified under product code HRS for orthopedic hand fixation.
Can the Level One Hand Plating System be used in MRI environments?
The available data does not specify whether the Level One Hand Plating System is MRI-safe. If MRI imaging is required post-surgery, it is essential to consult the manufacturer’s guidelines or additional documentation to ensure compatibility and avoid potential risks associated with magnetic fields.