510(k) · Cleared
ClearedMicro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with #3-0 Orthocord Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · HWC Screw, Fixation, Bone
Cleared on Mar 12, 2008 as substantially equivalent to K032078 (Mitek Worldwide, 2003) and 4 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1996. 4 later devices descend from it.
- Decided
- Mar 12, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K962793 (1996). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK962793 Mitek Micro AnchorMitek Products · 1996
- 1 generation backK032078 Mitek Micro QuickanchorMitek Worldwide · 2003
- This deviceK080352 Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix…Depuy Mitek, A Johnson & Johnson Company · 2008
- Descendant · cites it directly · 2 of its ownK110879 Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK254229 Arthrex Nano FiberTak Suture AnchorArthrex, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK140908 Juggerknot Mini Soft AnchorBiomet Sports Medicine · 2014
- Descendant · cites it directly · 0 of its ownK123668 OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company · 2013
Most influential descendants
Showing 4 of 4 · See all- K110879Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · cites it directly2descendants
- K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc. · 2026 · 2 generations on0descendants
- K140908Juggerknot Mini Soft AnchorBiomet Sports Medicine · 2014 · cites it directly0descendants
- K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962793 | Mitek Micro Anchor | Mitek Products | 1996 | — |
| −1 | K032078 | Mitek Micro Quickanchor | Mitek Worldwide | 2003 | — |
| 0 (this device) | K080352 | Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+… | Depuy Mitek, A Johnson & Johnson Company | 2008 | — |
| +1 | K110879 | Biomet Sports Medicine Juggerknot (TM) Mini Soft Anchor | Biomet Sports Medicine | 2011 | 2 |
| +2 | K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | 2026 | — |
| +1 | K140908 | Juggerknot Mini Soft Anchor | Biomet Sports Medicine | 2014 | — |
| +1 | K123668 | Orthocord | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032078 | Mitek Micro QuickanchorSummary page 1…/ Microfix QA+ Anchor Substantial Equivalence Micro QA+ Anchor with Orthocrod is substantially equivalent to: Micro QA+ Anchor, K032078, K982420, K962793 and K96251 1, manufactured by DePuy Mitek. Mic… | 2003 |
| * | K982420 | Mitek Micro AnchorSummary page 1…x QA+ Anchor Substantial Equivalence Micro QA+ Anchor with Orthocrod is substantially equivalent to: Micro QA+ Anchor, K032078, K982420, K962793 and K96251 1, manufactured by DePuy Mitek. Microfix QA+… | 1998 |
| * | K962793 | Mitek Micro AnchorSummary page 1…hor Substantial Equivalence Micro QA+ Anchor with Orthocrod is substantially equivalent to: Micro QA+ Anchor, K032078, K982420, K962793 and K96251 1, manufactured by DePuy Mitek. Microfix QA+ Anchor w… | 1996 |
| * | K962511 | Mitek Micro AnchorSummary page 1…ntial Equivalence Micro QA+ Anchor with Orthocrod is substantially equivalent to: Micro QA+ Anchor, K032078, K982420, K962793 and K96251 1, manufactured by DePuy Mitek. Microfix QA+ Anchor with Orthocord… | 1996 |
| * | K024115 | Microfix Quickanchor PlusSummary page 1…by DePuy Mitek. Microfix QA+ Anchor with Orthocord is substantially equivalent to: Microfix QA+ Anchor, K024115, manufactured by DePuy Mitek Device Classification Bone anchors/screws are classified by the FDA as Class 11 Medical… | 2003 |
What descends from it? (4)
3 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 12 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K110879 (Biomet Sports Medicine, 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
The Micro QuickAnchor Plus is indicated for fixation of non-absorbable braided polyester or partially absorbable braided composite surgical suture to bone. This product is intended for the indications listed below: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits. Skull: Lateral canthoplasty…
Read the full statement (129 words)
The Micro QuickAnchor Plus is indicated for fixation of non-absorbable braided polyester or partially absorbable braided composite surgical suture to bone. This product is intended for the indications listed below:
Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits.
Skull: Lateral canthoplasty
The Microfix QuickAnchor Plus is indicated for fixationof soft tissue to bone, using suture for the in dications listed below.
Hand: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits.
Skull: Soft tissue attached to the parietal. Temporal ridge, frontal, mandible, maxilla, zygoma, and periobital bones of the skull.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080352: Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with #3-0 Orthocord Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080352
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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