# K210784: Extended HA Half Pins

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 2, 2021 after 17 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
Longest line of descent: 4 generations back to K953397 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023921: Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2003) Summary page 4.
- K033289: Modification to Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2004) Summary page 4.

## Indications for use
The Extended HA Half Pins are intended to be used with an external fixation system for fixation of fractures of long bones, joint fusions, and limb lengthening or deformity corrections that involve cutting of the bone and temporary stabilization for the indications listed below. 1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 2. Open and closed fracture fixation 3. Pseudarthrosis of long bones 4. Limb lengthening by distraction 5. Correction of bony or soft tissue deformities 6. Joint arthrodesis 7. Infected fractures 8. Nonunions

Source page: https://510kreport.com/device/K210784
Methodology: https://510kreport.com/methodology