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510(k) K091067

5.5 POLARIS SPINAL SYSTEM by Biomet Spine — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2009
Date Received
April 14, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Biomet Spine

  • K152622 — Alta ACDF System (July 8, 2016)
  • K153695 — Biomet Spine Fusion System (January 21, 2016)
  • K151974 — Polaris Spinal System (November 13, 2015)
  • K151064 — Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge (August 12, 2015)
  • K151483 — Biomet Spine Fusion System (July 31, 2015)
  • K151224 — Lineum OCT Spine System (June 30, 2015)
  • K142634 — Biomet Spine Fusion System (March 12, 2015)
  • K141791 — BIOMET FUSION SYSTEM (October 9, 2014)
  • K141804 — POLARIS SPINAL SYSTEM - HA COATED (September 25, 2014)
  • K121130 — POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS (June 15, 2012)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)