510(k) · Cleared
ClearedSURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthium Medtech Limited · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 28, 2023 as substantially equivalent to K121861 (Smith & Nephew, Inc., 2012) after a 272-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Dec 28, 2023
- Review
- 272 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050021 (2005). 11 ancestors in all, the oldest K925573 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK050021 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2005
- 3 generations backK070216 Vari-Lase Bright Tip FiberVascular Solutions, Inc. · 2007
- 2 generations backK072332 Vari-Lase Wire FiberVascular Solutions, Inc. · 2008 · Recalled
- 1 generation backK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012
- This deviceK230891 SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantHealthium Medtech Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050021 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2005 | — |
| −3 | K070216 | Vari-Lase Bright Tip Fiber | Vascular Solutions, Inc. | 2007 | — |
| −2 | K072332 | Vari-Lase Wire Fiber | Vascular Solutions, Inc. | 2008 | 1 |
| −1 | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra… | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K230891 | SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant | Healthium Medtech Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 3 | 0 |
| 2010 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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 |
|---|---|---|---|
| * | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Summary page 6…Table 1 – List of Predicate Device Device Name 510(k) Number Smith & Nephew FAST-FIX 360 Meniscal K121861 Repair System 1.4. Device Description The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside me… | 2012 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 7 other devices also cite its predicate K121861.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230891: SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230891
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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