510(k) · Cleared
ClearedMichelangelo Bunion System - Mabs, Model: MA6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instratek, Inc. · HTN Washer, Bolt Nut
Cleared on Aug 14, 2009 as substantially equivalent to K082384 (Instratek, Inc., 2008) and 1 other predicate after a 59-day review. Its family tree reaches back 9 generations to 1979. 4 later devices descend from it.
- Decided
- Aug 14, 2009
- Review
- 59 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K792022 (1979). 43 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 1 generation backK082384 Hav-Lok Bunion Correction SystemInstratek, Inc. · 2008
- This deviceK091763 Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK111032 CMC Cable FixInstratek, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK200332 EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2020
- Descendant · 3 generations on · 0 of its ownK242311 EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2024
- Descendant · cites it directly · 0 of its ownK183094 CyclaPlex Correction SystemCycla Orthopedics, Ltd. · 2019
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 1 generation backK082384 Hav-Lok Bunion Correction SystemInstratek, Inc. · 2008
- This deviceK091763 Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K111032CMC Cable FixInstratek, Inc. · 2011 · cites it directly2descendants
- K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2020 · 2 generations on1descendant
- K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2024 · 3 generations on0descendants
- K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −2 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −1 | K082384 | Hav-Lok Bunion Correction System | Instratek, Inc. | 2008 | — |
| 0 (this device) | K091763 | Michelangelo Bunion System - Mabs, Model: MA6000 | Instratek, Inc. | 2009 | — |
| +1 | K111032 | CMC Cable Fix | Instratek, Inc. | 2011 | — |
| +2 | K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020 | — |
| +3 | K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2024 | — |
| +1 | K183094 | CyclaPlex Correction System | Cycla Orthopedics, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 HTN? 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K082384 | Hav-Lok Bunion Correction SystemSummary page 1…n name: Button/Suture Device classification WasherBolt Nut, HTN at 21 CFR 888.3030 name: Legally marketed HAV-Lok Bunion Correction System, K082384 devices to which the Arthrex Mini-Tightrope, K061925 device is substantially equivalent:… | 2008 |
| * | K061925 | Mini Tightrope Repair Kit, Model AR-8911DSSummary page 1…asherBolt Nut, HTN at 21 CFR 888.3030 name: Legally marketed HAV-Lok Bunion Correction System, K082384 devices to which the Arthrex Mini-Tightrope, K061925 device is substantially equivalent:… | 2006 |
What descends from it? (4)
2 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 30 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 43 ancestors have a recall of any class.
- Of its descendants, K111032 (Instratek, Inc., 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Michelangelo Bunion System is intended for the following surgical indication:
To assist in the correction of hallux valgus deformities by providing reduction of the 1 st intermetatarsal angle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091763: Michelangelo Bunion System - Mabs, Model: MA6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091763
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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