510(k) · Cleared
ClearedInnova Telescopic Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innova Corp. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Feb 10, 1999 as substantially equivalent to K960297 (Howmedica Corp., 1996) after an 85-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Feb 10, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864403 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864403 | Monticelli Spinelli External Fixation System | Howmedica Corp. | 1986 | — |
| −1 | K960297 | Mandibular Bone Distractor II | Howmedica Corp. | 1996 | — |
| 0 (this device) | K984117 | Innova Telescopic Distractor | Innova Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQN device
- #1 K220050 KLS Martin IPS Distractionscore 5.0 · 5 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960297 | Mandibular Bone Distractor IISummary page 2…ivalence to the previously cleared devices intended for use in distraction osteogenesis, such as the Howmedica, Inc. Mandibular Distractor I, cleared as K960297. The devices share the same intended use and principle of operation. The devices share similar technological characteristics. Th… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K960297.
How does its category compare?
All MQN devicesMQN External Mandibular Fixator And/Or Distractor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MQN
292in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQN
34in 2025
MAUDE reports naming product code MQN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 77 | 0 | 5 |
| 2008 | 3 | 292 | 0 | 8 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 1 | — | 0 | 107 |
| 2013 | 0 | — | 0 | 179 |
| 2014 | 1 | — | 1 | 57 |
| 2015 | 1 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 87 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 1 | — | 0 | 108 |
| 2019 | 1 | — | 0 | 122 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 101 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (97 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984117 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984117: Innova Telescopic Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984117
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026