510(k) Report

510(k) · Cleared

Cleared

Pro-Toe X-Flex Hammertoe Fixation System

K141714510(k) TraditionalCleared Oct 24, 2014121-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · HTY Pin, Fixation, Smooth

Cleared on Oct 24, 2014 as substantially equivalent to K101165 (Wrightmedicaltechnologyinc, 2010) and 5 other predicates after a 121-day review. Its family tree reaches back 6 generations to 2002.

Decided
Oct 24, 2014
Review
121 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K013888 (2002). 22 ancestors in all, the oldest K902307 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 2 other ancestors2012: 1 other ancestor2010: 1 other ancestor2007: 2 other ancestors2002: 1 other ancestor1997: 1 other ancestor2008: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1996: 2 other ancestors1990: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestorK013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 2002K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 2003K062863 · Osteomed Extended 2.0/2.4CANNULATED Screw System · Osteomed LP · 2006K111536 · Metasurg Digifuse Implant · Metasurg · 2011K122959 · Hammer Toe Implant · Trilliant Surgical, Ltd. · 2012 · recalledK140148 · Pro-Toe Hammertoe Fixation System · Wrightmedicaltechnologyinc · 2014199019952000200520102015
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors3 generations back: 4 other ancestors4 generations back: 1 other ancestor5 generations back: 3 other ancestors K140148 · Pro-Toe Hammertoe Fixation System · Wrightmedicaltechnologyinc · 2014K122959 · Hammer Toe Implant · Trilliant Surgical, Ltd. · 2012 · recalledK111536 · Metasurg Digifuse Implant · Metasurg · 2011K062863 · Osteomed Extended 2.0/2.4CANNULATED Screw System · Osteomed LP · 2006K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 2003K013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 2002−50
  1. Root · 6 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
  2. 5 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
  3. 4 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
  4. 3 generations backK111536 Metasurg Digifuse ImplantMetasurg · 2011
  5. 2 generations backK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
  6. 1 generation backK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
  7. This deviceK141714 Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K013888Fixation (Steinmann) PinsMiltex, Inc.2002—
−5K031050PCW Percutaneous Compression WireMillennium Medical Technologies, Inc.2003—
−4K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP2006—
−3K111536Metasurg Digifuse ImplantMetasurg2011—
−2K122959Hammer Toe ImplantTrilliant Surgical, Ltd.20121
−1K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc2014—
0 (this device)K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510
199620
199710
199810
200010
200110
200210
200720
200810
201010
201210
201320
FIG. 1 — Lineage of K141714, 2002–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K101165Pro-Toe VO Hammertow Implant System
Summary page 4
…21 CFR 888.3040- Class II Device Product Code, Device Panel: HTY - Orthopedic 3. Predicate Device:  PRO-TOE™ VO Hammertoe Implant System (K101165 & K120645)  MMI Smart Toe® Hammertoe Implant (K070598)  WMT Implantable K-Wires (K132895 & K140148)  Solana…
Wrightmedicaltechnologyinc2010—
*K120645Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition
Summary page 4
…888.3040- Class II Device Product Code, Device Panel: HTY - Orthopedic 3. Predicate Device:  PRO-TOE™ VO Hammertoe Implant System (K101165 & K120645)  MMI Smart Toe® Hammertoe Implant (K070598)  WMT Implantable K-Wires (K132895 & K140148)  Solana Surgical F…
Wrightmedicaltechnologyinc2012—
*K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse
Summary page 4
…Panel: HTY - Orthopedic 3. Predicate Device:  PRO-TOE™ VO Hammertoe Implant System (K101165 & K120645)  MMI Smart Toe® Hammertoe Implant (K070598)  WMT Implantable K-Wires (K132895 & K140148)  Solana Surgical FuseForce Implant System (K124045) 4. Device Descr…
Memometal Technologies2007—
*K132895WMT Implantable K-Wire
Summary page 4
…. Predicate Device:  PRO-TOE™ VO Hammertoe Implant System (K101165 & K120645)  MMI Smart Toe® Hammertoe Implant (K070598)  WMT Implantable K-Wires (K132895 & K140148)  Solana Surgical FuseForce Implant System (K124045) 4. Device Description The PRO-TOE® X-FLEX Hammer…
Wrightmedicaltechnologyinc2013—
*K140148Pro-Toe Hammertoe Fixation System
Summary page 4
…e Device:  PRO-TOE™ VO Hammertoe Implant System (K101165 & K120645)  MMI Smart Toe® Hammertoe Implant (K070598)  WMT Implantable K-Wires (K132895 & K140148)  Solana Surgical FuseForce Implant System (K124045) 4. Device Description The PRO-TOE® X-FLEX Hammer Fixation…
Wrightmedicaltechnologyinc2014—
*K124045Fuseforce Implant System
Summary page 4
…01165 & K120645)  MMI Smart Toe® Hammertoe Implant (K070598)  WMT Implantable K-Wires (K132895 & K140148)  Solana Surgical FuseForce Implant System (K124045) 4. Device Description The PRO-TOE® X-FLEX Hammer Fixation System is a super-elastic, nitinol device which pro…
Solana Surgical, LLC2013—

Also cleared against K101165: 13 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 12 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 3 of the 22 ancestors have a recall of any class.
  • 13 other devices also cite its predicate K101165.

How does its category compare?

All HTY devices

HTY 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

2007: 62008: 62009: 22010: 92011: 62012: 42013: 42014: 82015: 82016: 62017: 52018: 42019: 42020: 52021: 52022: 42023: 52024: 12025: 52026 (partial year): 2
2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007: 112 days median2008: 86 days median2010: 180 days median2011: 82 days median2012: 76 days median2013: 128 days median2014: 73 days median2015: 101 days median2016: 114 days median2017: 127 days median2018: 162 days median2019: 93 days median2020: 108 days median2021: 137 days median2022: 121 days median2023: 146 days median2025: 90 days median
2007high 180 (2010) · low 73 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HTY

2in 2022

2009: 12010: 12016: 22019: 12022: 22026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HTY

39in 2025

2007: 462008: 382009: 362010: 332011: 1642012: 1292013: 1872014: 1492015: 1212016: 1282017: 822018: 1382019: 2222020: 2102021: 1482022: 962023: 1532024: 2972025: 39
2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076112046
2008686038
20092—136
20109180133
20116820164
20124760129
201341280187
20148730149
201581010121
201661142128
20175127082
201841620138
20194931222
202051080210
202151370148
20224121296
202351460153
20241—0297
2025590039
20262—1—

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 as stated in the FDA summary.

Also cleared against K101165

13 other devices cite the same predicate.

  • K211944Medline UNITE® Digital Fusion Screw SystemMedline Industries, Inc. · 2021
  • K191424Interphalangeal Joint Fusion Device RangeNeosteo · 2019
  • K172485Footmotion HammerToeNewclip Technics · 2018
  • K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc. · 2017
  • K142490ProxiFuse Hammer Toe DeviceCartiva, Inc. · 2014
  • K141937Trident Fusion ImplantVilex IN Tennessee, Inc. · 2014

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311 FDA decisions under this applicant name. See the company

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The HTY category page

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https://510kreport.com/device/K141714 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141714: Pro-Toe X-Flex 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/K141714

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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