510(k) · Cleared
ClearedStryker Pediatric Mandible Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · MQN External Mandibular Fixator And/Or Distractor
Cleared on Mar 20, 2014 as substantially equivalent to K062851 (Osteomed LP, 2006) and 2 other predicates after a 134-day review. Its family tree reaches back 8 generations to 1979. 1 later device descends from it.
- Decided
- Mar 20, 2014
- Review
- 134 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K792561 (1979). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 7 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 6 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- 5 generations backK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- 4 generations backK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
- 3 generations backK013618 Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002
- 2 generations backK043434 Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005
- 1 generation backK062851 Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006
- This deviceK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- Descendant · cites it directly · 0 of its ownK181504 Stryker Pediatric Mandibular Distractor 2Stryker · 2018
Most influential descendants
Showing 1 of 1 · See all- K181504Stryker Pediatric Mandibular Distractor 2Stryker · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −7 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −6 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K990944 | Osteomed Intraoral Distraction System | Osteomed Corp. | 1999 | — |
| −3 | K013618 | Intraoral Mandibular Distraction System | Osteomed Corp. | 2002 | — |
| −2 | K043434 | Osteomed Pediatric Intraoral Mandibular Distraction System | Osteomed LP | 2005 | — |
| −1 | K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, Extended | Osteomed LP | 2006 | — |
| 0 (this device) | K133398 | Stryker Pediatric Mandible Distractor | Stryker | 2014 | — |
| +1 | K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedSummary page 1…e Plate Predicate Devices: 1. OsteoMed Pediatric. lntraoral Mandibular Distraction System, Extended - K062851 2. KLS Micro Zurich Distractor (aka: Zurich Distraction… | 2006 |
| * | K010139 | Zurich Distraction SystemSummary page 1…tem, Extended - K062851 2. KLS Micro Zurich Distractor (aka: Zurich Distraction System) - K01 0139 3. Leibinger Advance Internal Midface Distraction… | 2001 |
| * | K092743 | The Leibinger Advance Internal Midface Distraction SystemSummary page 1…System) - K01 0139 3. Leibinger Advance Internal Midface Distraction System - K092743 Intended Use: The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the ma… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181504 | Stryker Pediatric Mandibular Distractor 2 | 2018 | 0 |
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 35 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K181504 (Stryker, 2018) has gone furthest, with 0 descendants of its own.
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. 2014, this device’s year, is highlighted.
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 Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandible Distractor is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133398 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133398: Stryker Pediatric Mandible Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133398
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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