Home / 510(k) Clearances / K152253

510(k) K152253

Biomet Microfixation RibFix Blu Thoracic Fixation System by Biomet Microfixation — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2016
Date Received
August 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Biomet Microfixation

  • K241709 — Pectus Blu Support Bar System (September 19, 2024)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K212782 — SternaLock Sternal Closure System (May 17, 2022)
  • K212608 — RibFix Blu Thoracic Fixation System (April 22, 2022)
  • K213712 — Pectus Support Bar System (March 11, 2022)
  • K213208 — Twist Drills (December 23, 2021)
  • K202969 — Biomet Microfixation OmniMax MMF System (August 5, 2021)
  • K190576 — WalterLorenz Surgical Assist Arm Scope Holder (June 5, 2019)
  • K162974 — Biomet Microfixation RibFix Blu Thoracic Fixation System (December 9, 2016)
  • K163007 — Biomet Microfixation SternaLock 360 Sternal Closure System (November 23, 2016)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)