510(k) · Cleared
Recalled · Class I · 2014Synthes (Usa) Craniomaxillofacial Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · MQN External Mandibular Fixator And/Or Distractor
Cleared on Jun 2, 2006 after a 134-day review. The FDA summary names its predicate without a number. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Jun 2, 2006
- Review
- 134 days
- Class
- Class II
- Product code
- MQN
- Recalls
- 2 (1 Class I)
- Predicates
- 0
5 later devices descend from it, 5 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK060138 Synthes (Usa) Craniomaxillofacial Distraction SystemSynthes (Usa) · 2006
- Descendant · cites it directly · 1 of its ownK170818 Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC · 2017
- Descendant · cites it directly · 1 of its ownK121502 Synthes Curvilinear Distraction SystemSynthes, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK192702 DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020
- Descendant · cites it directly · 0 of its ownK183113 DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
- Descendant · cites it directly · 0 of its ownK162594 Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC · 2017
Most influential descendants
Showing 5 of 5 · See all- K170818Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC · 2017 · cites it directly1descendant
- K121502Synthes Curvilinear Distraction SystemSynthes, Inc. · 2012 · cites it directly1descendant
- K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020 · cites it directly0descendants
- K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
- K162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060138 | Synthes (Usa) Craniomaxillofacial Distraction System | Synthes (Usa) | 2006 | — |
| +1 | K170818 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017 | — |
| +1 | K121502 | Synthes Curvilinear Distraction System | Synthes, Inc. | 2012 | — |
| +1 | K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | 2020 | — |
| +1 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
| +1 | K162594 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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.
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? (2)
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 |
|---|---|---|---|
| * | — | KLS Martin - Zurich Distraction System Named without a submission number | |
| * | — | KLS Martin - Micro Zurich Distractor Named without a submission number |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170818 | Craniomaxillofacial Distraction System (CMFD) | 2017 | 1 |
| K121502 | Synthes Curvilinear Distraction System | 2012 | 1 |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | 2020 | 0 |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 2019 | 0 |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | 2017 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2014 | Class I | Z-2148-2014 | Device Design | DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively. |
| Jun 12, 2013 | Class II | Z-1726-2013 | Nonconforming Material/Component | The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K170818 (Synthes USA Products, LLC, 2017) has gone furthest, with 1 descendant 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.
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 Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The Synthes CMF Distraction System is intended for single use only. The Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer…
Read the full statement (111 words)
The Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The Synthes CMF Distraction System is intended for single use only.
The Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required in children under the age of 12 months. The Synthes Pediatric CMF Distraction System is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060138: Synthes (Usa) Craniomaxillofacial Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060138
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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