510(k) · Cleared
Recalled · Class I · 2019Natrelle 133 Plus Tissue Expander
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan, Inc. · LCJ Tissue Expander And Accessories
Cleared on Aug 20, 2015 as substantially equivalent to K130813 (Mentor Corp., 2013) after a 269-day review. Its family tree reaches back 2 generations to 2001. 1 of the 6 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Aug 20, 2015
- Review
- 269 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011500 (2001). 3 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK011500 Mentor Contour Profile Tissue ExpanderMentor Corp. · 2001
- 1 generation backK130813 Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture…Mentor Corp. · 2013 · Recalled
- This deviceK143354 Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK182054 Natrelle 133S Tissue ExpanderAllergan · 2018
- Descendant · 2 generations on · 0 of its ownK254126 Natrelle 133S Tissue ExpandersAbbVie · 2026
- Descendant · cites it directly · 0 of its ownK180826 Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011500 | Mentor Contour Profile Tissue Expander | Mentor Corp. | 2001 | — |
| −1 | K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast… | Mentor Corp. | 2013 | 4 |
| 0 (this device) | K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | 2015 | — |
| +1 | K182054 | Natrelle 133S Tissue Expander | Allergan | 2018 | — |
| +2 | K254126 | Natrelle 133S Tissue Expanders | AbbVie | 2026 | — |
| +1 | K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | Allergan | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue…Summary page 4…Inflatable Product Code: LCJ Predicate Device: Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders (K130813) Device Description: The Natrelle® 133 Plus Tissue Expanders are designed to develop tissue flaps as part of 2- sta… | 2013 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2019 | Class I | Z-2456-2019 | Unknown/Undetermined by firm | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K182054 (Allergan, 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K130813.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The Natrelle® 133 Plus Tissue Expanders 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/K143354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143354: Natrelle 133 Plus Tissue Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143354
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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