Kls-Martin Sternal Plating System
510(k) K032413
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032413 | Date10 Oct 2003 | 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- Withdrawn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 KLS-Martin L1 Sternal Plating System is a medical device classified as a sternal plating system (Product Code: HRS) designed for stabilizing and fixating the sternum. It is used in reconstructive procedures, trauma cases, or planned osteotomies to ensure secure closure of the chest wall, including sternal fractures. The system employs a ratcheted locking mechanism to provide adjustable fixation across varying sternal widths.
This system is supplied as a reusable medical device and is intended for use in operating room settings. It includes components such as a two-piece clamping device with configurable foot depths and lengths, along with a screw guide for enhanced surgeon efficiency. The device holds FDA 510(k) clearance (K032413) under the Traditional review pathway, with a decision date of October 10, 2003. Sterility and MRI safety are not specified in the provided data.
Other devices from KLS-Martin L.P.
Questions
AI-generated answers, 19 Sep 2026
Is the KLS-Martin L1 Sternal Plating System designed for single-use or can it be reused in multiple procedures?
The KLS-Martin L1 Sternal Plating System is explicitly described as a reusable medical device, intended for use in operating room settings across multiple procedures. Since it is not marked as single-use, it can be sterilized and reused following standard medical device reprocessing protocols.
What types of surgical cases is this sternal plating system primarily intended for?
The system is designed for reconstructive procedures, trauma cases involving sternal fractures, or planned osteotomies where secure sternal closure is required. It provides adjustable fixation to stabilize the chest wall, ensuring proper alignment during healing.
How does the KLS-Martin L1 Sternal Plating System adjust to different sternal widths?
The system features a two-piece clamping device with configurable foot depths and lengths, allowing surgeons to customize the fit for varying sternal widths. This adjustability, combined with a ratcheted locking mechanism, ensures secure fixation across different patient anatomies.
What components are included in the KLS-Martin L1 Sternal Plating System kit?
The kit includes a two-piece clamping device (with adjustable foot depths/lengths), a screw guide to streamline placement, and associated hardware for secure sternal fixation. These components are designed to enhance surgeon efficiency during reconstructive or trauma procedures.
How was the FDA clearance for this device determined, and what does that mean for its regulatory status?
The device holds FDA 510(k) clearance (K032413) under the Traditional review pathway, with a decision dated October 10, 2003. The clearance was granted under the Substantially Equivalent (SESE) determination, meaning it was found to be as safe and effective as a legally marketed predicate device. This does not imply current approval status but confirms the device met regulatory requirements at the time of submission.