510(k) · Cleared
ClearedPRO-TOE Hammertoe Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone
Cleared on Sep 4, 2015 as substantially equivalent to K132895 (Wrightmedicaltechnologyinc, 2013) and 1 other predicate after a 60-day review. Its family tree reaches back 6 generations to 2002. 4 later devices descend from it.
- Decided
- Sep 4, 2015
- Review
- 60 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K013888 (2002). 16 ancestors in all, the oldest K954330 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- 5 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- 4 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- 3 generations backK111536 Metasurg Digifuse ImplantMetasurg · 2011
- 2 generations backK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
- 1 generation backK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
- This deviceK151838 PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2015
- Descendant · cites it directly · 3 of its ownK190926 Hammertoe Truss System (HTS)4Web, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK221283 Hammertoe Truss System (HTS)4Web Medical, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK250613 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K190926Hammertoe Truss System (HTS)4Web, Inc. · 2019 · cites it directly3descendants
- K221283Hammertoe Truss System (HTS)4Web Medical, Inc. · 2022 · 2 generations on2descendants
- K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024 · 3 generations on1descendant
- K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| −5 | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| −4 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| −3 | K111536 | Metasurg Digifuse Implant | Metasurg | 2011 | — |
| −2 | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | 1 |
| −1 | K140148 | Pro-Toe Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2014 | — |
| 0 (this device) | K151838 | PRO-TOE Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2015 | — |
| +1 | K190926 | Hammertoe Truss System (HTS) | 4Web, Inc. | 2019 | — |
| +2 | K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022 | — |
| +3 | K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024 | — |
| +4 | K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K132895 | WMT Implantable K-WireSummary page 4…Classification Name - Reference: 21 CFR 888.3040- Class II Product Code - Device Panel: HWC - Orthopedic 3. Predicate Device: K132895 - WMT Implantable K-Wire K140148 - PRO-TOE® Hammertoe… | 2013 |
| * | K140148 | Pro-Toe Hammertoe Fixation SystemSummary page 4…ct Code - Device Panel: HWC - Orthopedic 3. Predicate Device: K132895 - WMT Implantable K-Wire K140148 - PRO-TOE® Hammertoe Fixation System 4. Device Description The PRO-TOE® Hamm… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190926 | Hammertoe Truss System (HTS) | 2019 | 3 |
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 13 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K190926 (4Web, Inc., 2019) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K132895.
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 PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems, with the exception of the PRO-TOE® X-FLEX, can be used with Implantable K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint). The Implantable…
Read the full statement (117 words)
The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of osteotomies and reconstruction of the lesser toes
following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems, with the exception of the PRO-TOE® X-FLEX, can be used
with Implantable K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of
other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe
following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151838: PRO-TOE 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/K151838
Report an extraction error
Are you the manufacturer?
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