SternaLock Sternal Closure System
510(k) K212782
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212782 | Date17 May 2022 | 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- Withdrawn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, 1 Oct 2026
The SternaLock Sternal Closure System is a medical device classified as a sternal closure device (product code HRS) designed for the stabilization and fixation of sternal fractures during reconstructive procedures. It employs rigid fixation principles to ensure secure closure of the sternum, supporting both primary sternal closure and reconstructive applications in patients with varying bone quality.
This system is intended for use in surgical settings, including median sternotomies and minimally invasive approaches such as mini-sternotomy or mini-thoracotomy. Supplied sterile for single-use, it is regulated under FDA 510(k) clearance (K212782) as substantially equivalent to existing orthopedic devices. No additional regulatory markings or MRI safety classifications are specified in the available data.
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Questions
AI-generated answers, 1 Oct 2026
What is the SternaLock Sternal Closure System used for?
The SternaLock Sternal Closure System is designed specifically for stabilizing and fixing sternal fractures during reconstructive surgeries. It employs rigid fixation principles to ensure a secure closure of the sternum, making it suitable for both primary sternal closure and reconstructive applications. This includes procedures like median sternotomies and minimally invasive approaches such as mini-sternotomy or mini-thoracotomy, where bone quality may vary.
Is the SternaLock Sternal Closure System supplied sterile and for single-use?
Yes, the SternaLock Sternal Closure System is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining the integrity of the device for one surgical procedure.
What types of surgical procedures can use the SternaLock Sternal Closure System?
The system is intended for use in surgical settings involving sternal closure, including median sternotomies and minimally invasive procedures such as mini-sternotomy or mini-thoracotomy. Its rigid fixation design supports reconstructive applications where secure sternal stabilization is critical.
How is the SternaLock Sternal Closure System regulated?
The SternaLock Sternal Closure System has received FDA 510(k) clearance under the classification of orthopedic devices (product code HRS). It was determined to be substantially equivalent to existing orthopedic devices, with the clearance granted on May 17, 2022, following a traditional review process.
Does the SternaLock Sternal Closure System have any specific MRI safety considerations?
The available data does not specify any MRI safety classifications for the SternaLock Sternal Closure System. If MRI compatibility is required for post-operative imaging, clinicians should verify compatibility with the device’s materials and construction before use.