# K013888: Fixation (Steinmann) Pins

- Pathway: 510(k) (Traditional)
- Applicant: Miltex, Inc.
- Decided: May 1, 2002 after 159 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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.
315 later devices descend from it; 1 cites it directly.
0 of 316 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 no predicate by number.

## Most influential descendants
- K031050: PCW Percutaneous Compression Wire (2003), 314 descendants of its own
- 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

## Indications for use
1. Itis the intention of Miltex Inc. to introduce into the marketplace a line of Fixation/Steinmann Pins bath Smooth and Threaded. 2. The material is 316LVM, Stainless Steel and the Pins are to be utilized for internal! fixation of bone fractures. 3. The Pins are used specifically for fractures of the proximal or distal end of long bones such as intracapsular intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur. 4. The device(s) may be implanted or attached through the skin so that a pulling force (traction) may be applicd to the skeletal system.

Source page: https://510kreport.com/device/K013888
Methodology: https://510kreport.com/methodology