510(k) · Cleared
ClearedMeniscus Versaflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GM Dos Reis Industria e Comercio Ltda. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Feb 19, 2026 as substantially equivalent to K203393 (Smith & Nephew, Inc., 2021) and 1 other predicate after a 58-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- Feb 19, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K961555 (1996). 34 ancestors in all, the oldest K925573 (1993). No later device cites it as a predicate yet.
- Root · 11 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations between
- 3 generations backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
- 2 generations backK251145 Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025
- 1 generation backK252664 GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025
- This deviceK254188 Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026
Show all 11 generations
- Root · 11 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 10 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 9 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 8 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 7 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 6 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 5 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- 4 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 3 generations backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
- 2 generations backK251145 Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025
- 1 generation backK252664 GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025
- This deviceK254188 Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −10 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −9 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −8 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −7 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −6 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −5 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| −4 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| −3 | K151092 | Arthrex Short Suture Anchors | Arthrex, Inc. | 2016 | — |
| −2 | K251145 | Arthrex PushLock Suture Anchors | Arthrex, Inc. | 2025 | — |
| −1 | K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | 2025 | — |
| 0 (this device) | K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 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 |
|---|---|---|---|
| * | K203393 | Fast-Fix FlexSummary page 5…21 CFR 878.5000 III. Predicate Devices: Legally marketed devices to which we are claiming “Substantial Equivalence” are the following: Fast-fix Flex - Smith&Nephew (K203393) (Primary predicate device). GMReis Suture Anchors - GMReis (K252664) (Reference device). IV. Device Description: Meniscus Vers… | 2021 |
| * | K252664 | GMReis Suture AnchorsSummary page 5…to which we are claiming “Substantial Equivalence” are the following: Fast-fix Flex - Smith&Nephew (K203393) (Primary predicate device). GMReis Suture Anchors - GMReis (K252664) (Reference device). IV. Device Description: Meniscus Versaflex - All Inside Meniscal Suture with Bendable Tip is an arthroscop… | 2025 |
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 30 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 34 ancestors have a recall of any class.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
Meniscus Versaflex is indicated for repair of the meniscus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254188: Meniscus Versaflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254188
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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