Polaris BE Rods
510(k) K071377
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071377 | Date6 Aug 2007 | 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- Withdrawn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
- KWP
- FDA applicant
- Biomet Spine
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
Polaris BE Rods are spinal fixation rods intended for use in spinal fusion surgery to provide stabilization of the spine. The rods are classified as an Appliance, Fixation, Spinal Interlaminal device (product code KWP) and are listed as Class II with special controls. They are manufactured from commercially pure titanium or stainless steel and have a 6.35 mm diameter, available in single or double bullet‑ended configurations for the Jackson Intrasacral Fixation Technique.
The rods are supplied by Biomet Spine (Parsippany, NJ, USA) and were cleared by the FDA through a traditional 510(k) submission (K071377) on August 6 2007, with a decision of substantially equivalent. They are intended for use in the operating‑room setting as part of a larger spinal construct that may include hooks or screws. The device is provided as a sterile, single‑use component and must be stored according to the manufacturer’s instructions.
Other devices from Biomet Spine LLC
Questions
AI-generated answers, 6 Oct 2026
What material are Polaris BE Rods made from and why is that important?
The rods are manufactured from commercially pure titanium or stainless steel. These materials provide high strength, biocompatibility, and corrosion resistance, which are essential for maintaining stable fixation while minimizing the risk of adverse tissue reactions during spinal fusion surgery.
In what configurations are the rods supplied and how does that affect surgical use?
Polaris BE Rods are available in single‑bullet‑ended or double‑bullet‑ended configurations. The single‑ended version allows attachment to a single fixation point, while the double‑ended design enables connection to two points, offering flexibility in constructing a spinal construct that matches the surgeon’s technique and the patient’s anatomy.
Are the rods sterile and intended for multiple uses?
Yes, the rods are supplied sterile and are designated as a single‑use component. Single‑use sterility ensures that each rod remains free of contaminants, and re‑sterilization is not recommended because it could compromise the material integrity and compromise patient safety.
How should Polaris BE Rods be stored before use?
The rods must be stored according to Biomet Spine’s instructions, typically in a controlled environment that protects them from moisture, extreme temperatures, and physical damage. Proper storage preserves sterility and the mechanical properties of the titanium or stainless‑steel rods until they are used in the operating room.