# K013616: Polarus Cap Screw

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Dec 19, 2001 after 44 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) set screw for the Howmedica Vitallium IM Device: named in the summary without a submission number
- (no number) Ace Medical AIM Titanium Humeral Nail System’s end cap: named in the summary without a submission number
- (no number) Alta IM Rod’s cap screw: named in the summary without a submission number
- (no number) SynthesTitanium Solid Humeral Nail System’s end cap: named in the summary without a submission number

## Indications for use
The Polarus Cap Screw is intended to be used in conjunction with the Polarus Rod family cleared under K920666 and K951740. Its purpose is to engage the proximal-most 5.0 interlocking screw in the rod to prohibit/minimize backing out of that screw and to prohibit ingrowth of bone into the 1/4-20 hole.

Source page: https://510kreport.com/device/K013616
Methodology: https://510kreport.com/methodology