510(k) · Cleared
ClearedMectaLock Ti Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Sep 12, 2019 as substantially equivalent to K041713 (Linvatec Corp., 2004) and 2 other predicates after a 121-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Sep 12, 2019
- Review
- 121 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K003984 (2001). 8 ancestors in all, the oldest K945203 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003984 Super Revo Suture AnchorLinvatec Corp. · 2001
- 1 generation backK041713 Super Revo Herculine Suture AnchorLinvatec Corp. · 2004
- This deviceK191300 MectaLock Ti Suture AnchorMedacta International S.A. · 2019
- Descendant · cites it directly · 2 of its ownK223582 MectaLock TI Triple Loaded Suture AnchorMedacta International S.A. · 2023
- Descendant · 2 generations on · 1 of its ownK230544 SnugFit All-Suture Anchor extensionMedacta International S.A. · 2023
- Descendant · 3 generations on · 0 of its ownK251933 SnugFit ASA ExtensionMedacta International S.A. · 2025
Most influential descendants
Showing 3 of 3 · See all- K223582MectaLock TI Triple Loaded Suture AnchorMedacta International S.A. · 2023 · cites it directly2descendants
- K230544SnugFit All-Suture Anchor extensionMedacta International S.A. · 2023 · 2 generations on1descendant
- K251933SnugFit ASA ExtensionMedacta International S.A. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003984 | Super Revo Suture Anchor | Linvatec Corp. | 2001 | — |
| −1 | K041713 | Super Revo Herculine Suture Anchor | Linvatec Corp. | 2004 | — |
| 0 (this device) | K191300 | MectaLock Ti Suture Anchor | Medacta International S.A. | 2019 | — |
| +1 | K223582 | MectaLock TI Triple Loaded Suture Anchor | Medacta International S.A. | 2023 | — |
| +2 | K230544 | SnugFit All-Suture Anchor extension | Medacta International S.A. | 2023 | — |
| +3 | K251933 | SnugFit ASA Extension | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K041713 | Super Revo Herculine Suture AnchorSummary page 4…ation 11 III. Predicate Device Substantial equivalence is claimed to the following device: Primary Predicate: » ConMed Linvatec, SuperRevo® Herculine ™ Suture Anchor (K041713). Additional Predicates: » Medacta International SA, M-ARS ACL: Anatomic Ribbon Surgery System (K171640) » DePuy Mitek, FASTIN R… | 2004 |
| * | K171640 | M-ARS ACL: Anatomic Ribbon Surgery SystemSummary page 4…dicate: » ConMed Linvatec, SuperRevo® Herculine ™ Suture Anchor (K041713). Additional Predicates: » Medacta International SA, M-ARS ACL: Anatomic Ribbon Surgery System (K171640) » DePuy Mitek, FASTIN RC Anchor (K060664) IV. Device Description The MectaLock TI Suture anchor is an implantable device used f… | 2017 |
| * | K060664 | Fastin RC AnchorSummary page 4…uline ™ Suture Anchor (K041713). Additional Predicates: » Medacta International SA, M-ARS ACL: Anatomic Ribbon Surgery System (K171640) » DePuy Mitek, FASTIN RC Anchor (K060664) IV. Device Description The MectaLock TI Suture anchor is an implantable device used for the soft tissues refixation (i.e.: mus… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223582 | MectaLock TI Triple Loaded Suture Anchor | 2023 | 2 |
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 2 companies; a new generation was cleared every 15.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K223582 (Medacta International S.A., 2023) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K041713.
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. 2019, 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 MectaLock Ti Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure:
• Shoulder: cuff rotator repair and biceps tenodesis.
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/K191300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191300: MectaLock Ti Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191300
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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