510(k) · Cleared
Recalled · Class II · 2026ARTOURA Breast Tissue Expanders with Smooth Surface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Worldwide, LLC · LCJ Tissue Expander And Accessories
Cleared on May 23, 2016 as substantially equivalent to K150777 (Mentor Worldwide, LLC, 2015) after a 27-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- May 23, 2016
- Review
- 27 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011500 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK011500 Mentor Contour Profile Tissue ExpanderMentor Corp. · 2001
- 3 generations backK130813 Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture…Mentor Corp. · 2013 · Recalled
- 2 generations backK142998 CPX Control Breast Tissue ExpanderMentor Worldwide, LLC · 2014
- 1 generation backK150777 Artoura Breast Tissue ExpanderMentor Worldwide, LLC · 2015 · Recalled
- This deviceK161176 ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC · 2016
- Descendant · cites it directly · 0 of its ownK244026 PAL 7020 ConsoleMicroaire Surgical Instruments, LLC · 2025
- Descendant · cites it directly · 0 of its ownK242963 MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLC · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011500 | Mentor Contour Profile Tissue Expander | Mentor Corp. | 2001 | — |
| −3 | K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast… | Mentor Corp. | 2013 | 4 |
| −2 | K142998 | CPX Control Breast Tissue Expander | Mentor Worldwide, LLC | 2014 | — |
| −1 | K150777 | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | 2015 | 2 |
| 0 (this device) | K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | 2016 | — |
| +1 | K244026 | PAL 7020 Console | Microaire Surgical Instruments, LLC | 2025 | — |
| +1 | K242963 | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 LCJ? 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 LCJ device
- #1 K254126 Natrelle 133S Tissue Expandersscore 11.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K150777 | Artoura Breast Tissue ExpanderSummary page 4…Regulation: Panel: General & Plastic Surgery Product Code: LCJ III. PREDICATE DEVICE K150777, MENTOR® ARTOURA™ Breast Tissue Expanders This predicate has not been subjected to a design-related recall or any type… | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2026 | Class II | Z-1687-2026 | Under Investigation by firm | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| Feb 18, 2026 | Class II | Z-1686-2026 | Under Investigation by firm | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K244026 (Microaire Surgical Instruments, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LCJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCJ
525in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCJ
496in 2025
MAUDE reports naming product code LCJ, 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 | 1 | — | 0 | 10 |
| 2008 | 0 | — | 0 | 24 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 58 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 31 |
| 2013 | 1 | — | 0 | 47 |
| 2014 | 3 | 256 | 0 | 20 |
| 2015 | 2 | — | 0 | 13 |
| 2016 | 3 | 153 | 0 | 38 |
| 2017 | 0 | — | 0 | 111 |
| 2018 | 3 | 29 | 0 | 518 |
| 2019 | 0 | — | 0 | 554 |
| 2020 | 0 | — | 0 | 639 |
| 2021 | 0 | — | 0 | 440 |
| 2022 | 0 | — | 0 | 499 |
| 2023 | 3 | 525 | 1 | 473 |
| 2024 | 1 | — | 0 | 488 |
| 2025 | 2 | — | 0 | 496 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MENTOR ® ARTOURA™ Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161176: ARTOURA Breast Tissue Expanders with Smooth Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161176
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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