# K131636: Polarus Connect

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Oct 10, 2013 after 128 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K841189 (1984). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 1.
- K091425: Quantum M Composite Nailing System, N.M.B. Medical Applications, Ltd. (2010) Summary page 1.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 2.
- K951740: Intramedulary Fixation Rod, Acu Med, Inc. (1995) Summary page 2.

## Indications for use
The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.

Source page: https://510kreport.com/device/K131636
Methodology: https://510kreport.com/methodology