510(k) · Cleared
ClearedToegrip, Implant for Proximal Inter-Phalangeal Arthrodesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synchro Medical · HTY Pin, Fixation, Smooth
Cleared on Feb 10, 2014 as substantially equivalent to K031712 (Inion, Ltd., 2003) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1996. 9 later devices descend from it.
- Decided
- Feb 10, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K960385 (1996). 9 ancestors in all, the oldest K901456 (1990). 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 1 generation backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- This deviceK133477 Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical · 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 · cites it directly · 2 of its ownK132912 Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · Recalled
- Descendant · 4 generations on · 1 of its ownK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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
- K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · cites it directly2descendants
- K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −2 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −1 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| 0 (this device) | K133477 | Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis | Synchro Medical | 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 | — |
| +1 | K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant | In2bones Sas | 2014 | 2 |
| +4 | K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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? (3)
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 |
|---|---|---|---|
| * | K031712 | Inion Otps Biodegradable PinSummary page 1…ion fastener and Number 21 CFR 888.3040 Classification Panel: Orthopedic Product Code HTY Predicate Devices Inion OTPS Biodegradable Pin (K031712), Memometal InCTM Smart Toe & X-Fuse (K070598) & New Deal K-Wire (K022599) Previo… | 2003 |
| * | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseSummary page 1…nel: Orthopedic Product Code HTY Predicate Devices Inion OTPS Biodegradable Pin (K031712), Memometal InCTM Smart Toe & X-Fuse (K070598) & New Deal K-Wire (K022599) Previous Submissions There are no previous submissions… | 2007 |
| * | K022599 | Newdeal K WireSummary page 1…ate Devices Inion OTPS Biodegradable Pin (K031712), Memometal InCTM Smart Toe & X-Fuse (K070598) & New Deal K-Wire (K022599) Previous Submissions There are no previous submissions K133477… | 2002 |
What descends from it? (9)
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 18 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K160264 (Additive Orthopaedics, LLC, 2016) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K031712.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The TOEGRIP® is intended for toes for general use in skeletally mature individuals undergoing surgery limited to interdigital fusion.
The TOEGRIP® device is intended to be permanently implanted without any other additional device as an intramedullary bone fastener device for toes or fingers.
The TOEGRIP® device is indicated for small bone reconstruction limited to interdigital fusion of toes in the following cases, listed in random order:
* Rigid PIP joints deformities
* Rigid hammertoes deformities
* Claw toes deformities (PIP and DIP joints)
* Revision hammertoes surgeries
* Shortening osteotomies of the proximal phalanx
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133477 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133477: Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133477
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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