510(k) · Cleared
ClearedMeta-Lock Suture Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tarsus Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Sep 27, 2011 as substantially equivalent to K051989 (Depuy Mitek, A Johnson & Johnson Company, 2005) after a 189-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Sep 27, 2011
- Review
- 189 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K915889 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK915889 Mitek Bone Anchor, ModificationMitek Surgical Products, Inc. · 1992
- 2 generations backK041115 Gii Quickanchor PlusDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
- 1 generation backK051989 Gii Quickanchor Plus with Orthocord SutureDepuy Mitek, A Johnson & Johnson Company · 2005
- This deviceK110800 Meta-Lock Suture Anchor SystemTarsus Medical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915889 | Mitek Bone Anchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −2 | K041115 | Gii Quickanchor Plus | Depuy Mitek, A Johnson & Johnson Company | 2004 | 1 |
| −1 | K051989 | Gii Quickanchor Plus with Orthocord Suture | Depuy Mitek, A Johnson & Johnson Company | 2005 | — |
| 0 (this device) | K110800 | Meta-Lock Suture Anchor System | Tarsus Medical, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | K051989 | Gii Quickanchor Plus with Orthocord SutureSummary page 1…construction, ITB tendonesis; patellar ligament and tendon avulsions. Predicate Device GIl QuickAnchor Plus K05 1989 Manufactured by Depuy Mitek Device Description The Meta-LockTM Suture Anchor System is a suture anchor used for the reattachment… | 2005 |
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 19 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K051989.
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. 2011, 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 Tarsus Medical Meta-Lock Suture Anchor System is intended for fixation of suture to bone for the indications listed below: SHOULDER: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis; deltoid repair ANKLE: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstructions FOOT: Hallux valgus reconstruction WRIST…
Read the full statement (104 words)
The Tarsus Medical Meta-Lock Suture Anchor System is intended for fixation of suture to bone for the indications listed below:
SHOULDER: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis; deltoid repair
ANKLE: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstructions
FOOT: Hallux valgus reconstruction
WRIST: Scapholunate ligament
HAND: Ulnar or lateral collateral ligament reconstruction
ELBOW: Biceps tendon reattachment
KNEE: Extra capsular repairs; reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tendonesis; patellar ligament and tendon avulsions.
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/K110800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110800: Meta-Lock Suture Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110800
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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