# K982068: Howmedica Titanium Hoffmann Fixation Pin System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Aug 31, 1998 after 80 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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) Howmedica® Hoffmann® Fixation Pin System: named in the summary without a submission number
- (no number) Smith & Nephew-Richards Titanium Alloy Half Pins: named in the summary without a submission number

## Indications for use
The Howmedica® Titanium Hoffmann® Fixation Pin System is intended to be used in conjunction with a rigid external supporting frame for immobilization open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

Source page: https://510kreport.com/device/K982068
Methodology: https://510kreport.com/methodology