PERIMETER C (Titanium) Spinal System
by Medtronic Sofamor Danek USA, Inc.
510(k) K153438
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153438 | Date2 Mar 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- Withdrawn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
- 510(k) Number
- FDA product code
- ODP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Perimeter C (Titanium) Spinal System is an orthopedic spinal fixation device designed for internal stabilization of the spine. It consists of titanium components intended to provide structural support and alignment correction in spinal surgeries, such as fusions or deformity corrections. The system includes screws, rods, and connectors engineered to distribute load and maintain spinal integrity. Its construction prioritizes biocompatibility and mechanical stability for long-term use.
This system is supplied sterile and intended for single-use in surgical settings. It is classified under product code ODP (Orthopedic Devices, Spinal) and was cleared via the FDA’s Special 510(k) pathway, with a clearance decision dated March 2, 2016. Titanium components ensure compatibility with MRI environments, though specific MRI safety parameters should be verified preoperatively. Storage requires adherence to sterile packaging protocols to preserve integrity until use.
Other devices from Medtronic Sofamor Danek, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Perimeter C (Titanium) Spinal System used for?
The Perimeter C (Titanium) Spinal System is designed for internal stabilization of the spine during surgeries such as spinal fusions or deformity corrections. Its titanium components provide structural support and help maintain proper spinal alignment by distributing load across screws, rods, and connectors. This ensures mechanical stability and long-term integrity of the spine.
Is the Perimeter C (Titanium) Spinal System sterile and single-use?
Yes, the Perimeter C (Titanium) Spinal System is supplied sterile and intended for single-use in surgical settings. This ensures patient safety by preventing cross-contamination and maintaining the device’s integrity for one surgical procedure only.
Can this system be used in MRI environments?
The titanium components of the Perimeter C (Titanium) Spinal System are compatible with MRI environments, but it is critical to verify specific MRI safety parameters preoperatively. Titanium is generally non-ferromagnetic, reducing the risk of artifacts or interference, though individual MRI protocols may vary.
How should the Perimeter C (Titanium) Spinal System be stored?
The system must be stored according to sterile packaging protocols to preserve its integrity until use. This includes keeping the packaging unopened, protected from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions to ensure sterility and functionality.
What regulatory pathway was used for FDA clearance of this device?
The Perimeter C (Titanium) Spinal System was cleared via the FDA’s Special 510(k) pathway, determined to be substantially equivalent to a predicate device. The clearance decision was made by the Orthopedic (OR) Advisory Committee on March 2, 2016, under product code ODP (Orthopedic Devices, Spinal).