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510(k) K131636

POLARUS CONNECT by Acumed, LLC — Product Code LXT

K131636 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "POLARUS CONNECT". The FDA issued a decision of Substantially Equivalent on October 10, 2013. The device falls under product code LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite), a Class II device regulated under 21 CFR 888.3030. Acumed, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2013
Date Received
June 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Acumed, LLC

  • K252356 — The Acumed Wrist Fixation System - 2.4mm Screws (August 21, 2025)
  • K251132 — The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Sc (July 14, 2025)
  • K251296 — The Acumed Wrist Fixation System (June 18, 2025)
  • K243624 — Acu-Sinch Knotless Mini (January 23, 2025)
  • K233311 — Acumed Wrist Plating System (April 22, 2024)
  • K230744 — Acumed Acutrak 3 Headless Compression Screw System (June 9, 2023)
  • K221333 — Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional (December 29, 2022)
  • K212990 — Acumed Ankle Syndesmosis Repair System (January 7, 2022)
  • K210750 — Acumed Clavicle Hook Plating System (July 15, 2021)
  • K151886 — Acumed Ankle and Small Fragment Base Set Update (October 30, 2015)

Other clearances for product code LXT

  • K230067 — Para-Fix External Fixation System (September 22, 2023)
  • K132704 — DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW (October 9, 2013)
  • K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMS (October 31, 2011)
  • K090374 — STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 (March 11, 2009)
  • K073135 — SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS (January 29, 2008)
  • K063832 — SYNTHES (USA) ELBOW HINGE FIXATOR (March 7, 2007)
  • K060864 — MULTIDIRECTIONAL THREADED PEG (April 28, 2006)
  • K060403 — PTA (PROGRESSIVE TIBIAL ALIGNMENT) (March 28, 2006)
  • K060290 — SHOULDER FIXATION SYSTEM (February 27, 2006)
  • K052754 — WRIST FUSION PLATE (October 27, 2005)

FDA data resources