510(k) · Cleared
ClearedMinilok Quickanchor Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Worldwide · HWC Screw, Fixation, Bone
Cleared on Jun 26, 2003 as substantially equivalent to K930892 (Mitek Surgical Products, Inc., 1994) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1992. 12 later devices descend from it.
- Decided
- Jun 26, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K921873 (1992). 6 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 1 generation backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- This deviceK030995 Minilok Quickanchor PlusMitek Worldwide · 2003
- Descendant · cites it directly · 8 of its ownK071257 Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company · 2007
- Descendant · 2 generations on · 1 of its ownK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
- Descendant · cites it directly · 1 of its ownK153585 Flip Button Suture AnchorFirst Ray, LLC · 2016
- Descendant · 3 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K071257Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company · 2007 · cites it directly8descendants
- K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021 · 2 generations on1descendant
- K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · 2 generations on1descendant
- K153585Flip Button Suture AnchorFirst Ray, LLC · 2016 · cites it directly1descendant
- K253538TeKBrace Knotless AnchorTheramicro · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −1 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| 0 (this device) | K030995 | Minilok Quickanchor Plus | Mitek Worldwide | 2003 | — |
| +1 | K071257 | Mini Quickanchor and Quickanchor Plus with Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2007 | — |
| +2 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021 | — |
| +2 | K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020 | — |
| +1 | K153585 | Flip Button Suture Anchor | First Ray, LLC | 2016 | — |
| +3 | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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.
Planning a device in HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930892 | Mitek Mini Anchor, ModificationSummary page 1…: MINILOK QuickAnchor Plus Substantial Equivalence MINILOK QuickAnchor Plus is substantially equivalent to: Mini QuickAnchor Plus (K930892, K992487 and K992623) and MicroFix QuickAnchor Plus (KO224 1 15) manufactured by Mitek… | 1994 |
| * | K992487 | Mitek Mini Quickanchor PlusSummary page 1…INILOK QuickAnchor Plus Substantial Equivalence MINILOK QuickAnchor Plus is substantially equivalent to: Mini QuickAnchor Plus (K930892, K992487 and K992623) and MicroFix QuickAnchor Plus (KO224 1 15) manufactured by Mitek… | 1999 |
| * | K992623 | Mitek Mini AnchorSummary page 1…Anchor Plus Substantial Equivalence MINILOK QuickAnchor Plus is substantially equivalent to: Mini QuickAnchor Plus (K930892, K992487 and K992623) and MicroFix QuickAnchor Plus (KO224 1 15) manufactured by Mitek Worldwide… | 1999 |
| Kept off the family tree | K022415 | FDA’s K022415 is Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST Our reading of the summary gave K022415, FDA’s number for Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST (Waismed, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MicroFix QuickAnchor Plus”. Kept off the family tree. | 2002 |
| * | K022234 | Arthrex Wrist Bio-Anchor, Model AR-1322BSummary page 1…MA 02062. In addition, the MINILOK QuickAnchor Plus is substantially equivalent to the absorbable Mini Bio-Anchor, K022234, manufactured by Arthrex, Inc., in Naples, Florida. Device Classification Bone anchors/screws a… | 2002 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K071257 (Depuy Mitek, A Johnson & Johnson Company, 2007) has gone furthest, with 8 descendants of its own.
- 8 other devices also cite its predicate K930892.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below:
Ankle: Mid-foot reconstruction
Foot: Hallux Valgus reconstruction
Hand: Ulnar or lateral collateral ligament reconstruction
Wrist: Scapholunate ligament reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030995: Minilok Quickanchor Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030995
Report an extraction error
Are you the manufacturer?
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