Polyaxial Hemispherical Spinal Screws

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K051063 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• MX Monoaxial Pedicle Screw

  Class II

  FDA 510(k) K042964 Active Cleared 22 Nov 2004

• Isobar Semi-Rigid Dual Dampener

  Class II

  FDA 510(k) K071261 Active Cleared 17 Apr 2008

• Stella Cervical Plate

  Class II

  FDA 510(k) K052763 Active Cleared 10 Nov 2005

• Ellys and Aurys Vertebral Body Replacements

  Class II

  FDA 510(k) K033109 Active Cleared 23 Mar 2004

• Biofill Bone Void Filler

  Class II

  FDA 510(k) K040454 Active Cleared 7 May 2004

• Aladyn Rigid Spine Plate

  Class II

  FDA 510(k) K040747 Active Cleared 17 Jun 2004

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• What is the intended use of the Polyaxial Hemispherical Spinal Screws?

  These screws are intended for posterior, noncervical pedicle and non-pedicle fixation in spinal fusion procedures. They are used to treat degenerative disc disease, spondylolisthesis, trauma, and spinal stenosis in skeletally mature patients receiving autogenous bone graft, as specified in the indications for use.

• How are the Polyaxial Hemispherical Spinal Screws supplied and are they reusable?

  The device is supplied as an implant for spinal fusion procedures. Based on its classification as a pedicle screw system and typical clinical use, it is intended for single-use implantation and is not designed or labeled for reuse.

• What regulatory pathway was used for the Polyaxial Hemispherical Spinal Screws?

  The device received FDA 510(k) clearance under submission number K051063, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance pathway is noted in the device data under AUTHORIZATIONS and decision_description.