510(k) · Cleared
ClearedStryker Pediatric Mandibular Distractor 2
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 Sep 11, 2018 as substantially equivalent to K133398 (Stryker, 2014) after a 96-day review. Its family tree reaches back 9 generations to 1979.
- Decided
- Sep 11, 2018
- Review
- 96 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K792561 (1979). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 5 generations between
- 3 generations backK043434 Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005
- 2 generations backK062851 Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006
- 1 generation backK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- This deviceK181504 Stryker Pediatric Mandibular Distractor 2Stryker · 2018
Show all 9 generations
- Root · 9 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 8 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 7 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- 6 generations backK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- 5 generations backK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
- 4 generations backK013618 Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002
- 3 generations backK043434 Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005
- 2 generations backK062851 Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006
- 1 generation backK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- This deviceK181504 Stryker Pediatric Mandibular Distractor 2Stryker · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −8 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −7 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| −6 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K990944 | Osteomed Intraoral Distraction System | Osteomed Corp. | 1999 | — |
| −4 | K013618 | Intraoral Mandibular Distraction System | Osteomed Corp. | 2002 | — |
| −3 | K043434 | Osteomed Pediatric Intraoral Mandibular Distraction System | Osteomed LP | 2005 | — |
| −2 | K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, Extended | Osteomed LP | 2006 | — |
| −1 | K133398 | Stryker Pediatric Mandible Distractor | Stryker | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K133398 | Stryker Pediatric Mandible DistractorSummary page 5…Review Panel Page 5-2 III. PREDICATE DEVICE [§807.92(a)(3)] Stryker Pediatric Mandible Distractor – K133398 IV. DEVICE DESCRIPTION [§807.92(a)(4)] The Stryker Pediatric Mandibular Distractor 2 (PMD 2) system is a distraction system co… | 2014 |
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 39 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- None of the 22 ancestors has a recall.
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. 2018, 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 Mandibular Distractor 2 is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandibular Distractor 2 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/K181504 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181504: Stryker Pediatric Mandibular Distractor 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181504
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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