510(k) Report

510(k) · Cleared

Cleared

EzFuze Implant System

K150211510(k) TraditionalCleared Nov 10, 2015284-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

Vilex IN Tennessee, Inc. · HWC Screw, Fixation, Bone

Cleared on Nov 10, 2015 as substantially equivalent to K141937 (Vilex IN Tennessee, Inc., 2014) and 7 other predicates after a 284-day review. Its family tree reaches back 5 generations to 2002.

Decided
Nov 10, 2015
Review
284 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
8

Its longest line of descent runs back 5 generations to K013888 (2002). 23 ancestors in all, the oldest K902307 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2012: 2 other ancestors2011: 1 other ancestor2010: 2 other ancestors2007: 2 other ancestors2002: 1 other ancestor2005: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors2001: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor1990: 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 · 2011K141937 · Trident Fusion Implant · Vilex IN Tennessee, Inc. · 2014199019952000200520102015
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 7 other ancestors3 generations back: 4 other ancestors4 generations back: 1 other ancestor K141937 · Trident Fusion Implant · Vilex IN Tennessee, Inc. · 2014K111536 · 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 · 5 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
  2. 4 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
  3. 3 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
  4. 2 generations backK111536 Metasurg Digifuse ImplantMetasurg · 2011
  5. 1 generation backK141937 Trident Fusion ImplantVilex IN Tennessee, Inc. · 2014
  6. This deviceK150211 EzFuze Implant SystemVilex IN Tennessee, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K013888Fixation (Steinmann) PinsMiltex, Inc.2002—
−4K031050PCW Percutaneous Compression WireMillennium Medical Technologies, Inc.2003—
−3K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP2006—
−2K111536Metasurg Digifuse ImplantMetasurg2011—
−1K141937Trident Fusion ImplantVilex IN Tennessee, Inc.2014—
0 (this device)K150211EzFuze Implant SystemVilex IN Tennessee, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510
199620
199710
199810
200010
200110
200210
200510
200720
201020
201110
201220
201310
FIG. 1 — Lineage of K150211, 2002–2015Source: 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 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. #1 K203011 Monster Screw Systemscore 22.2 · 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? (8)

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
*K141937Trident Fusion Implant
Summary page 4
…– Smooth or threaded metallic bone fixation fastener Name: Product Code: HWC/ Orthopedics, Class II Predicate Devices: Trident Fusion Implant by Vilex (K141937) SmartToe and X-Fuse by Styker (K070598 and K112197) OSSplate Hammerlock by Bio…
Vilex IN Tennessee, Inc.2014—
*K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse
Summary page 4
…t Code: HWC/ Orthopedics, Class II Predicate Devices: Trident Fusion Implant by Vilex (K141937) SmartToe and X-Fuse by Styker (K070598 and K112197) OSSplate Hammerlock by BioMedical Enterprises (K091951 and K131640)…
Memometal Technologies2007—
*K112197Memometal Intra-Medullary Bone Fastener
Summary page 4
…HWC/ Orthopedics, Class II Predicate Devices: Trident Fusion Implant by Vilex (K141937) SmartToe and X-Fuse by Styker (K070598 and K112197) OSSplate Hammerlock by BioMedical Enterprises (K091951 and K131640) DigiFuse b…
Memometal Technologies20111
*K091951Hammerlock
Summary page 4
…t by Vilex (K141937) SmartToe and X-Fuse by Styker (K070598 and K112197) OSSplate Hammerlock by BioMedical Enterprises (K091951 and K131640) DigiFuse by Metasurg (K111536) eZ-Staple Superelastic Bone Fixatio…
Biomedical Ent., Inc.2010—
*K131640Smooth or Threaded Metallic Bone Fastener
Summary page 4
…K141937) SmartToe and X-Fuse by Styker (K070598 and K112197) OSSplate Hammerlock by BioMedical Enterprises (K091951 and K131640) DigiFuse by Metasurg (K111536) eZ-Staple Superelastic Bone Fixation Staple by…
Biomedical Ent., Inc.2013—
*K111536Metasurg Digifuse Implant
Summary page 4
…Styker (K070598 and K112197) OSSplate Hammerlock by BioMedical Enterprises (K091951 and K131640) DigiFuse by Metasurg (K111536) eZ-Staple Superelastic Bone Fixation Staple by Vilex (K112837) Newdeal K-wire…
Metasurg2011—
*K112837Vilex EZ-Staple (Memory Bone Fixation Staple)
Summary page 4
…Enterprises (K091951 and K131640) DigiFuse by Metasurg (K111536) eZ-Staple Superelastic Bone Fixation Staple by Vilex (K112837) Newdeal K-wire by Newdeal (K022599) Description of The Vilex EzFuze Implant System includes…
Vilex, Inc.2012—
*K022599Newdeal K Wire
Summary page 4
…igiFuse by Metasurg (K111536) eZ-Staple Superelastic Bone Fixation Staple by Vilex (K112837) Newdeal K-wire by Newdeal (K022599) Description of The Vilex EzFuze Implant System includes single-piece devices intended for the fixation of Device:…
New Deal, S.A.2002—

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 13 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
  • 2 of the 23 ancestors have a recall of any class.

How does its category compare?

All HWC devices

HWC 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

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The EzFuze Implants have the following Indications for Use:

Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

Indications for use as stated in the FDA summary.

More from Vilex IN Tennessee, Inc.

7 FDA decisions under this applicant name. See the company

  • K191289Bone Screw Line AdditionVilex IN Tennessee, Inc. · 2019
  • K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
  • K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017
  • K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. · 20162 recalls
  • K151456Small Bone Nail ImplantVilex IN Tennessee, Inc. · 2015

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K150211 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150211: EzFuze Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150211

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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