510(k) · Cleared
ClearedALVUE Balloon Dilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 7, 2018 as substantially equivalent to K090631 (PAJUNK GmbH Medizintechnologie, 2009) and 1 other predicate after a 252-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Mar 7, 2018
- Review
- 252 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K944418 (1994). 13 ancestors in all, the oldest K926010 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK944418 The Spacemaker and the Spacemaker IIGeneral Surgical Innovations · 1994
- 3 generations backK962702 Spacemaker Serial Surgical Balloon Dissector, with Cannula, with…General Surgical Innovations · 1997
- 2 generations backK973046 Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical…General Surgical Innovations · 1998
- 1 generation backK090631 Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009
- This deviceK171939 ALVUE Balloon Dilation SystemGlobus Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944418 | The Spacemaker and the Spacemaker II | General Surgical Innovations | 1994 | — |
| −3 | K962702 | Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization… | General Surgical Innovations | 1997 | — |
| −2 | K973046 | Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon… | General Surgical Innovations | 1998 | — |
| −1 | K090631 | Pajunk Disposable Balloons and Balloon Systems | PAJUNK GmbH Medizintechnologie | 2009 | — |
| 0 (this device) | K171939 | ALVUE Balloon Dilation System | Globus Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1997 | 1 | 0 |
| 2004 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K090631 | Pajunk Disposable Balloons and Balloon SystemsSummary page 4…s Product Code(s): GCJ Regulatory Class: II, Panel Code: 87 Primary Predicate: Pajunk Disposable Balloons and Balloon Systems (K090631) Predicates: Spacemaker Surgical Balloon Dissector (K973046) Reference AFFIRM™ VCF System (K110998) Devices… | 2009 |
| * | K973046 | Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, SaphtrakSummary page 4…atory Class: II, Panel Code: 87 Primary Predicate: Pajunk Disposable Balloons and Balloon Systems (K090631) Predicates: Spacemaker Surgical Balloon Dissector (K973046) Reference AFFIRM™ VCF System (K110998) Devices: CRE Balloon Dilatation Catheter (K110833)… | 1998 |
| † | K110998 | Affirm (TM) VCF System | 2011 |
| † | K110833 | Cre Balloon Dilatation Catheter | 2011 |
| † | K132383 | Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation Catheter | 2014 |
| † | K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter | 2015 |
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 24 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K090631.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The ALVUE™ Balloon Dilation System is indicated for patients undergoing surgical procedures requiring tissue retraction including the following procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery; spine surgery; orthopedic surgery; thoracoscopic surgery; and procedures in the extraperitoneal space. The system is intended to create an operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal, subcutaneous extremity, or thoracic space.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171939: ALVUE Balloon Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171939
Report an extraction error
Are you the manufacturer?
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