# K963433: Threaded Fixation Pin

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Biosystems, Ltd.
- Decided: Nov 6, 1996 after 68 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.
317 later devices descend from it; 2 cite it directly.
0 of 318 devices 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) Synthes Threaded Kirschner Wires: named in the summary without a submission number

## Most influential descendants
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System (2006), 310 descendants of its own
- K103705: Low Profile Screws (2011), 219 descendants of its own
- K111253: Arthrex Distal Extremity Plate System (2011), 135 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own

## Indications for use
Both function as internal alignment and fixation for small bones of the hand and foot

Source page: https://510kreport.com/device/K963433
Methodology: https://510kreport.com/methodology