510(k) · Cleared
ClearedResolve Quickanchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Products · DZL Screw, Fixation, Intraosseous
Cleared on Dec 29, 1999 as substantially equivalent to K970896 (ETHICON, Inc., 1997) and 3 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Dec 29, 1999
- Review
- 69 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K915889 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915889 | Mitek Bone Anchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −1 | K992611 | Mitek Rotator Cuff Quickanchor Plus | Mitek Products | 1999 | — |
| 0 (this device) | K993575 | Resolve Quickanchor | Mitek Products | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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 DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K970896 | Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor SystemSummary page 1…on: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Product Code: JDR (21 CFR 888.3030) Predicate Devices: K970896 - Mitek Panalok Anchor K962511, K982420 - Mitek Micro Anchor K992611 — Mitek Rotator Cuff QuickAnchor Plus Product Description:… | 1997 |
| * | K962511 | Mitek Micro AnchorSummary page 1…the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Product Code: JDR (21 CFR 888.3030) Predicate Devices: K970896 - Mitek Panalok Anchor K962511, K982420 - Mitek Micro Anchor K992611 — Mitek Rotator Cuff QuickAnchor Plus Product Description: The device described in this 51… | 1996 |
| * | K982420 | Mitek Micro AnchorSummary page 1…ral Food, Drug, and Cosmetic Act, the device classification is Class II. Product Code: JDR (21 CFR 888.3030) Predicate Devices: K970896 - Mitek Panalok Anchor K962511, K982420 - Mitek Micro Anchor K992611 — Mitek Rotator Cuff QuickAnchor Plus Product Description: The device described in this 510(k) is a… | 1998 |
| * | K992611 | Mitek Rotator Cuff Quickanchor PlusSummary page 1…Act, the device classification is Class II. Product Code: JDR (21 CFR 888.3030) Predicate Devices: K970896 - Mitek Panalok Anchor K962511, K982420 - Mitek Micro Anchor K992611 — Mitek Rotator Cuff QuickAnchor Plus Product Description: The device described in this 510(k) is a sterile implant used to anch… | 1999 |
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 7 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 5 ancestors has a recall.
- 8 other devices also cite its predicate K970896.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ReSolve™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications:
Cranio/Maxillofacial:
Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.
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/K993575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993575: Resolve Quickanchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993575
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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