510(k) · Cleared
ClearedSynthes Curvilinear Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes, Inc. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Aug 23, 2012 as substantially equivalent to K080153 (Synthes (Usa), 2008) and 3 other predicates after a 94-day review. Its family tree reaches back 7 generations to 1979. 1 of the 19 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 23, 2012
- Review
- 94 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K792561 (1979). 17 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 6 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 5 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- 4 generations backK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- 3 generations backK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
- 2 generations backK013618 Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002
- 1 generation backK043434 Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005
- This deviceK121502 Synthes Curvilinear Distraction SystemSynthes, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK183113 DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
Class I recalls in this family
- K060138 Synthes (Usa) Craniomaxillofacial Distraction…direct predicate · 2006
Most influential descendants
Showing 1 of 1 · See all- K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −6 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −5 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K990944 | Osteomed Intraoral Distraction System | Osteomed Corp. | 1999 | — |
| −2 | K013618 | Intraoral Mandibular Distraction System | Osteomed Corp. | 2002 | — |
| −1 | K043434 | Osteomed Pediatric Intraoral Mandibular Distraction System | Osteomed LP | 2005 | — |
| 0 (this device) | K121502 | Synthes Curvilinear Distraction System | Synthes, Inc. | 2012 | — |
| +1 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
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 |
| 2001 | 1 | 0 |
| 2006 | 1 | 1 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (4)
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 |
|---|---|---|---|
| * | K080153 | Synthes (Usa) Curvilinear Distraction SystemSummary page 1…Classification Name Class 11, 21 CFR 872.4760, Product Code MQN Predicate Devices * Synthes Curvilinear Distraction System (K080153) * Syntheg CraniomaxillofaciaI (CMF) Distraction System (K060138) * OsteoMed Intraoral Mandibular Distrac… | 2008 |
| * | K060138 | Synthes (Usa) Craniomaxillofacial Distraction SystemSummary page 1…Code MQN Predicate Devices * Synthes Curvilinear Distraction System (K080153) * Syntheg CraniomaxillofaciaI (CMF) Distraction System (K060138) * OsteoMed Intraoral Mandibular Distraction Systcem (KO 1361 8) * OsteoMed Pediatric Intraoral Mandibula… | 2006 |
| * | K013618 | Intraoral Mandibular Distraction SystemSummary page 3…worm drive, whereas the Synthes Craniomaxillofacial (CME) Distraction System (K(060138) the OsteoMed Intraoral Mandibular Distraction System (K013618), and OsteoMed Pediatric Introral Mandibular Distraction System (K(043434) predicates employ a center lead screw.… | 2002 |
| * | K043434 | Osteomed Pediatric Intraoral Mandibular Distraction SystemSummary page 1…on System (K060138) * OsteoMed Intraoral Mandibular Distraction Systcem (KO 1361 8) * OsteoMed Pediatric Intraoral Mandibular Distraction System (K043434) Indications for Use The Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and… | 2005 |
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 |
|---|---|---|---|
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 2019 | 0 |
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 · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 17 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K183113 (Synthes (USA) Products, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080153.
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. 2012, 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 Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required.
The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old.
The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger.
The Synthes Curvilinear Distraction System is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121502: Synthes Curvilinear Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121502
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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