510(k) · Cleared
ClearedCraniomaxillofacial Distraction System (CMFD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA Products, LLC · MQN External Mandibular Fixator And/Or Distractor
Cleared on May 8, 2017 as substantially equivalent to K060138 (Synthes (Usa), 2006) after a 234-day review. Its family tree reaches back 1 generation to 2006. 1 of the 2 devices in its family, counting itself, has a Class I recall.
- Decided
- May 8, 2017
- Review
- 234 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060138 (2006). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK060138 Synthes (Usa) Craniomaxillofacial Distraction SystemSynthes (Usa) · 2006 · Recalled (Class I)
- This deviceK162594 Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC · 2017
Class I recalls in this family
- K060138 Synthes (Usa) Craniomaxillofacial Distraction…direct predicate · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060138 | Synthes (Usa) Craniomaxillofacial Distraction System | Synthes (Usa) | 2006 | Class I |
| 0 (this device) | K162594 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017 | — |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K060138 | Synthes (Usa) Craniomaxillofacial Distraction SystemSummary page 4…one plate Regulatory Class: Class II - 872.4760 Product Code: MQN 5.3.Predicate Devices Primary Predicate Device: Synthes Craniomaxillofacial Distraction System (K060138) Reference Device(s): Synthes Curvilinear Distraction System (K121502) 5.4.Indications for Use The DePuy Synthes CMF Dist… | 2006 |
| † | K121502 | Synthes Curvilinear Distraction System | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060138Synthes (Usa) Craniomaxillofacial Distraction SystemSynthes (Usa) · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- 4 other devices also cite its predicate K060138.
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. 2017, 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 DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only. Mandible • The 1.0…
Read the full statement (128 words)
The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only.
Mandible
• The 1.0 mm plates and screws are intended for neonates and infants under the age of 12 months
• The 1.3 mm plates and screws are intended for neonates, infants, and children 4 years of age and younger
• The 1.5 mm and 2.0 mm plates and screws are intended for infants, children, adolescents, and adults 1 year of age and older
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162594: Craniomaxillofacial Distraction System (CMFD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162594
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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