# K964500: Acumed Tension Band Pin

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Dec 9, 1996 after 31 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- 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) Acumed Fixation Pin: named in the summary without a submission number
- (no number) Howmedica Kirschner Wire: named in the summary without a submission number

## Recalls of this device
- Mar 26, 2014 · Class II · Z-1515-2014: Manufacturing of these devices with a grade of stainless steel that is not within specifications.

## Indications for use
The Acumed Tension Band Pin is used in conjunction with orthopedic wire to address malleolar, patella, and oleacranon fracture fixation in tension band wiring procedures. This device is not intended for usage in the spine.

Source page: https://510kreport.com/device/K964500
Methodology: https://510kreport.com/methodology