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 · PBJ Cranial Distraction System
Cleared on Dec 7, 2017 as substantially equivalent to K010139 (KLS-Martin L.P., 2001) and 1 other predicate after a 262-day review. Its family tree reaches back 1 generation to 2001. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 7, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- PBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010139 (2001). 2 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK010139 Zurich Distraction SystemKLS-Martin L.P. · 2001
- This deviceK170818 Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC · 2017
- Descendant · cites it directly · 0 of its ownK192702 DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020
Class I recalls in this family
- K060138 Synthes (Usa) Craniomaxillofacial Distraction…direct predicate · 2006
Most influential descendants
Showing 1 of 1 · See all- K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010139 | Zurich Distraction System | KLS-Martin L.P. | 2001 | — |
| 0 (this device) | K170818 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017 | — |
| +1 | K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 PBJ device
- #1 K230211 CranioXpandscore 7.9 · 6 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 |
|---|---|---|---|
| * | K010139 | Zurich Distraction SystemSummary page 4…Regulatory Class: Class II ‐ 882.5330 Product Code: PBJ Review Panel: Neurology 1.3.Predicate Devices Primary Predicate: Zurich Distraction System’s Arnaud Distractor (K010139) Additional Predicate: Synthes Craniomaxillofacial Distraction System (K060138) 1.4.Indications for Use The DePuy Synthes CMF D… | 2001 |
| * | K060138 | Synthes (Usa) Craniomaxillofacial Distraction SystemSummary page 4…1.3.Predicate Devices Primary Predicate: Zurich Distraction System’s Arnaud Distractor (K010139) Additional Predicate: Synthes Craniomaxillofacial Distraction System (K060138) 1.4.Indications for Use The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and… | 2006 |
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 |
|---|---|---|---|
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | 2020 | 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?
How does its category compare?
All PBJ devicesPBJ Cranial Distraction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PBJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PBJ
Too few PBJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PBJ
No recall names PBJ since 2007.
Adverse event reports per year · PBJ
4in 2025
MAUDE reports naming product code PBJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 4 |
| 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 cranium, where gradual bone distraction is required in adults and pediatric patients.
Cranium
The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170818: 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/K170818
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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