# K030336: Kmedic External Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical Group
- Decided: Mar 6, 2003 after 34 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: 2 generations back to K960385 (1996). 3 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 1.
- K022599: Newdeal K Wire, New Deal, S.A. (2002)
- (no number) George Tiemann & Co. Kirschner Wires, Steinmann Pins and Cerclage Wires - Preamendment: named in the summary without a submission number

## Most influential descendants
- K121008: Trilliant Surgical K-Wires (2012), 7 descendants of its own
- K102215: Kirschner Wires, Steinman Pins (2010), 6 descendants of its own
- K161449: HammerTech Fixation System (2016), 5 descendants of its own
- K112254: Apex Kirschner Wires and Steinmann Pins (2011), 5 descendants of its own
- K201850: Vector Hammertoe Correction System (2020), 3 descendants of its own

## Indications for use
The KMedic External Fixation Devices are non-sterile, single-use, external fixation devices intended to be used for unilateral external fixation in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K030336
Methodology: https://510kreport.com/methodology