# K070561: Kmedic Internal/External Fixation Devices

- Pathway: 510(k) (Abbreviated)
- Applicant: Teleflex Medical
- Decided: May 25, 2007 after 87 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.
68 later devices descend from it; 3 cite it directly.
0 of 69 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) Zimmer K-Wires: named in the summary without a submission number
- (no number) Zimmer Steinmann Pins: named in the summary without a submission number
- (no number) Zimmer Schanz Screws: named in the summary without a submission number

## Most influential descendants
- K100736: Kirschner and Guide Wires (2010), 65 descendants of its own
- K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple (2012), 24 descendants of its own
- K131061: Restore Bunion Correction System (2013), 15 descendants of its own
- K131459: Aap K-Wire, Steinmann Pin, Cerclage Wire (2013), 12 descendants of its own
- K120787: Merete Locking Bone Plate System Iii (2012), 12 descendants of its own

## Indications for use
The KMedic® Internal/External Fixation Devices are non-sterile, single-use; internal/external fixation devices intended to be used for unilateral internal/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 internal/external fixation modality.

Source page: https://510kreport.com/device/K070561
Methodology: https://510kreport.com/methodology