# K152627: IFS Fixation Scaffold System

- Pathway: 510(k) (Traditional)
- Applicant: Metric Medical Devices, Inc.
- Decided: Jan 13, 2016 after 120 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
Longest line of descent: 5 generations back to K960385 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133520: Hammerlock 2, Biomedical Enterprises, Inc. (2014) Summary page 4.
- K863734: Steinmann (Threaded/Calibrated),Knowles&Hogie Pins, Micro-Aire Surgical Instruments, Inc. (1986) Summary page 4.
- K123363: Super Staple (TM) Classic, Metric Medical Devices, Inc. (2013) Summary page 4.

## Indications for use
The IFS Fixation Scaffold is indicated for small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes.

Source page: https://510kreport.com/device/K152627
Methodology: https://510kreport.com/methodology