510(k) · Cleared
ClearedSurgicraft Lockdown Acromioclavicular (AC) Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgicraft, Ltd. · HTN Washer, Bolt Nut
Cleared on Feb 15, 2011 as substantially equivalent to K052776 (Arthrex, Inc., 2005) after a 662-day review. Its family tree reaches back 7 generations to 1979. 3 later devices descend from it.
- Decided
- Feb 15, 2011
- Review
- 662 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K792022 (1979). 40 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 5 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 4 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 3 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 2 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 1 generation backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- This deviceK091207 Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK190143 LARS AC Band DeviceCorin USA · 2019
- Descendant · cites it directly · 0 of its ownK253115 Lars AcjMovmedix S.A.S. · 2026
- Descendant · cites it directly · 0 of its ownK153211 M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −6 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −5 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −4 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −3 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −2 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −1 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K091207 | Surgicraft Lockdown Acromioclavicular (AC) Device | Surgicraft, Ltd. | 2011 | — |
| +1 | K190143 | LARS AC Band Device | Corin USA | 2019 | — |
| +1 | K253115 | Lars Acj | Movmedix S.A.S. | 2026 | — |
| +1 | K153211 | M-Fix Acromioclavicular Device | Coracoid Solutions, Inc. | 2016 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 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 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 16.5 · 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? (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 |
|---|---|---|---|
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 2…edicate Device(s): The Surgicraft LOCKDOWNTM Acrornioclavicular (AC) device was shown to be substantially equivalent to the Arthrex TightRopeV Acromnioclavicular device (K052776) and has the same indications for use, function and/or materials. * The Surgicraft LOCKDO WAUm Acromioclavicular (AC) device… | 2005 |
What descends from it? (3)
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 32 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 40 ancestors have a recall of any class.
- Of its descendants, K190143 (Corin USA, 2019) has gone furthest, with 1 descendant of its own.
- 14 other devices also cite its predicate K052776.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Surgicraft LOCKDO WNTMAcronioclavicular (AC) device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromnioclavicular separations due to coracoclavicular ligament disruptions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091207: Surgicraft Lockdown Acromioclavicular (AC) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091207
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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