# K973484: Chin Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Dec 2, 1997 after 78 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 K792561 (1979). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972154: Cohen Distractor, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K901940: Luhr Micro Mesh, Howmedica Corp. (1990) Summary page 1.
- K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System, Walter Lorenz Surgical, Inc. (1995) Summary page 1.
- K874276: Cui, Versafil (TM), Ste (TM) Tissue Expander, Cox-Uphuff Intl. (1987) Summary page 1.

## Most influential descendants
- K030790: Osteomed Alveolar Distraction System (2003), 0 descendants of its own

## Indications for use
This device is intended for use in patients requiring alveolar ridge augmentation of the mandible or maxilla secondary. This includes conditions secondary to trauma, periodontal disease or birth abnormality. The device is intended to provide temporary stabilization and gradual expansion of the alveolar ridge.

Source page: https://510kreport.com/device/K973484
Methodology: https://510kreport.com/methodology