510(k) · Cleared
ClearedFastforward
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MedShape, Inc. · HTN Washer, Bolt Nut
Cleared on Dec 18, 2014 as substantially equivalent to K061925 (Arthrex, Inc., 2006) after a 203-day review. Its family tree reaches back 8 generations to 1979. 5 later devices descend from it.
- Decided
- Dec 18, 2014
- Review
- 203 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K792022 (1979). 42 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 6 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 5 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 4 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 3 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 2 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 1 generation backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- This deviceK141420 FastforwardMedShape, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK160264 Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK190926 Hammertoe Truss System (HTS)4Web, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK221283 Hammertoe Truss System (HTS)4Web Medical, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK250613 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC · 2016 · cites it directly4descendants
- K190926Hammertoe Truss System (HTS)4Web, Inc. · 2019 · 2 generations on3descendants
- K221283Hammertoe Truss System (HTS)4Web Medical, Inc. · 2022 · 3 generations on2descendants
- K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024 · 4 generations on1descendant
- K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −7 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −6 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −5 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −4 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −3 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −2 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −1 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| 0 (this device) | K141420 | Fastforward | MedShape, Inc. | 2014 | — |
| +1 | K160264 | Additive Orthopaedics Hammertoe Correction System | Additive Orthopaedics, LLC | 2016 | — |
| +2 | K190926 | Hammertoe Truss System (HTS) | 4Web, Inc. | 2019 | — |
| +3 | K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022 | — |
| +4 | K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024 | — |
| +5 | K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K061925 | Mini Tightrope Repair Kit, Model AR-8911DSSummary page 4…appliances and accessories 21 CFR 888.3030 E. Predicate Device(s): Arthrex Mini Tightrope, K061925 F. Physical Description: The FastForward device, consisting of Titanium (Ti-6AL-4V ELI), is a button de… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160264 | Additive Orthopaedics Hammertoe Correction System | 2016 | 4 |
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 35 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 42 ancestors have a recall of any class.
- Of its descendants, K160264 (Additive Orthopaedics, LLC, 2016) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K061925.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 FastForward device is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st Intermetatarsal angle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141420: Fastforward.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141420
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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