SternaLock 360 Sternal Closure System
510(k) K163007
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163007 | Date23 Nov 2016 | 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- Withdrawn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
- Full name
- Biomet Microfixation SternaLock 360 Sternal Closure System
- 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 SternaLock 360 Sternal Closure System is a sternal fixation device designed to approximate, compress, and rigidly fixate the sternum. It consists of plate and band combinations that provide 360-degree compression, ensuring stable closure for sternal fractures or post-sternotomy repair. The system accommodates varying patient anatomies and bone quality, including cases with compromised bone integrity.
This system is intended for use in surgical settings, where it is applied to stabilize sternal fractures or reconstruct sternal defects following procedures such as sternotomy. Supplied as a sterile, single-use device, it requires surgical implantation and is regulated under FDA 510(k) clearance (K163007). The system’s components are engineered for orthopedic applications, adhering to strict medical device compliance standards.
Other devices from Biomet Microfixation
Questions
AI-generated answers, 19 Sep 2026
What types of patients is the SternaLock 360 Sternal Closure System designed to help, and how does it adapt to different anatomies?
The SternaLock 360 Sternal Closure System is specifically designed for patients requiring sternal stabilization after procedures like sternotomy or for sternal fractures. It accommodates varying patient anatomies and bone quality, including cases where bone integrity may be compromised. The system achieves this through its plate and band combinations, which provide 360-degree compression, ensuring stable closure regardless of anatomical differences.
Is the SternaLock 360 Sternal Closure System intended for reuse, or is it meant to be used only once?
The SternaLock 360 Sternal Closure System is supplied as a sterile, single-use device. This means it is intended for one-time surgical use only and should not be reused after implantation, as reuse could compromise patient safety and device efficacy.
How is the SternaLock 360 Sternal Closure System regulated, and what does that mean for its use in clinical settings?
The SternaLock 360 Sternal Closure System is regulated under FDA 510(k) clearance with the designation K163007. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and performance standards for orthopedic use. Clinicians can rely on this regulatory pathway to confirm its compliance with medical device regulations.
What kind of surgical environment is required for the implantation of the SternaLock 360 Sternal Closure System?
The SternaLock 360 Sternal Closure System is designed for use exclusively in surgical settings. It requires direct implantation by a clinician during an operative procedure, such as sternal fracture repair or post-sternotomy reconstruction. The system is not intended for outpatient or non-surgical applications.
How should the SternaLock 360 Sternal Closure System be stored before use?
Since the SternaLock 360 Sternal Closure System is supplied as a sterile, single-use device, it should be stored in its original packaging in a clean, dry environment, protected from contamination and physical damage. Proper storage ensures sterility and maintains the device’s integrity until surgical use.