# K984117: Innova Telescopic Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Innova Corp.
- Decided: Feb 10, 1999 after 85 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- 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: 2 generations back to K864403 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960297: Mandibular Bone Distractor II, Howmedica Corp. (1996) Summary page 2.

## Indications for use
The Telescopic Distractor is an intraoral, subcutaneous distractor which is used for mandibular distraction osteogenesis. The device is indicated for use in patients with congenital micrognathia, post-traumatic mandibular deformities, or defects resulting from tumor resection. In conjunction with osteotomy or corticotomy, the Telescopic Distractor may be used for: • mandibular body lengthening; • mandibular ramus lengthening; • distraction osteogenesis across a mandibular segmental defect in the ramus, body, or symphysis; and • transport distraction osteogenesis across a mandibular segmental defect in the ramus, body, or symphysis. The device may be used in adult, adolescent, or pediatric patients.

Source page: https://510kreport.com/device/K984117
Methodology: https://510kreport.com/methodology