510(k) · Cleared
ClearedToeTac Hammertoe Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restore Surgical, LLC Dba Instratek · HWC Screw, Fixation, Bone
Cleared on Jun 4, 2015 as substantially equivalent to K133636 (Extremity Medical, LLC, 2014) and 1 other predicate after a 104-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Jun 4, 2015
- Review
- 104 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K962823 (1996). 68 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 5 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 4 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 3 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 2 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 1 generation backK112254 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011
- This deviceK150443 ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek · 2015
- Descendant · cites it directly · 0 of its ownK161778 ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek · 2016
Most influential descendants
Showing 1 of 1 · See all- K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −7 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −6 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −5 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −3 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −2 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −1 | K112254 | Apex Kirschner Wires and Steinmann Pins | Apex Tools & Orthopedics Co. | 2011 | — |
| 0 (this device) | K150443 | ToeTac Hammertoe Fixation System | Restore Surgical, LLC Dba Instratek | 2015 | — |
| +1 | K161778 | ToeTac™ 10° Hammertoe Fixation System | Restore Surgical, LLC Dba Instratek | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K133636 | Extremity Medical Hammertoe DeviceSummary page 4…: HWC Regulation/Description: 880.3040, Smooth or threaded metallic bone fixation Predicate Devices HammerFiX, K133636 Kirschner Wire, K112254 TM… | 2014 |
| * | K112254 | Apex Kirschner Wires and Steinmann PinsSummary page 4…880.3040, Smooth or threaded metallic bone fixation Predicate Devices HammerFiX, K133636 Kirschner Wire, K112254 TM Description of the device: The Instratek ToeTac Ha… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161778 | ToeTac™ 10° Hammertoe Fixation System | 2016 | 0 |
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 19 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 7 of the 68 ancestors have a recall of any class.
- Of its descendants, K161778 (Restore Surgical, LLC Dba Instratek, 2016) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K133636.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 ToeTacTM Hammertoe Fixation System indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150443: ToeTac Hammertoe Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150443
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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