510(k) Report

510(k) · Cleared

Cleared

Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365

K023684510(k) TraditionalCleared Mar 1, 2004486-day reviewClass II21 CFR 888.3730

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

Vilex, Inc. · KWD Prosthesis, Toe, Hemi-, Phalangeal

Cleared on Mar 1, 2004 after a 486-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it.

Decided
Mar 1, 2004
Review
486 days
Class
Class II
Product code
KWD
Recalls
None
Predicates
0

21 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2007: 1 descendant cleared2012: 2 descendants cleared2020: 1 descendant cleared2009: 2 descendants cleared2019: 2 descendants cleared2008: 2 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2013: 2 descendants cleared2024: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK023684 Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775…Vilex, Inc. · 2004
  2. Descendant · cites it directly · 18 of its ownK070052 Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007
  3. Descendant · 2 generations on · 15 of its ownK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
  4. Descendant · 3 generations on · 13 of its ownK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
  5. Descendant · cites it directly · 12 of its ownK083469 Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg · 2009
  6. Descendant · cites it directly · 11 of its ownK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 22011: 12012: 22013: 22016: 12017: 12019: 22020: 12021: 12022: 22024: 22026: 1
2007high 2 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 21 · See all
  • K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007 · cites it directly18descendants
  • K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008 · 2 generations on15descendants
  • K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008 · 3 generations on13descendants
  • K083469Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg · 2009 · cites it directly12descendants
  • K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011 · cites it directly11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023684Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675…Vilex, Inc.2004—
+1K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc.2007—
+2K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP2008—
+3K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP2008—
+1K083469Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg2009—
+1K102401Hemi Implant; Mini Hemi ImplantVilex, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200920
201110
201220
201320
201610
201710
201920
202010
202110
202220
202420
202610
FIG. 1 — Lineage of K023684, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWD? 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 KWD device

  1. #1 K250074 HYALEX® MTP Hemiarthroplasty Implantscore 13.2 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (21)

See all 21

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc.200718
K083469Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg200912
K102401Hemi Implant; Mini Hemi ImplantVilex, Inc.201111
K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195
K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201
K120029Hemi Phalangeal Implant Surgical Instrument SetSolana Surgical, LLC20120

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?

  • Of its descendants, K070052 (Vilex, Inc., 2007) has gone furthest, with 18 descendants of its own.

How does its category compare?

All KWD devices

KWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWD

1in 2024

2007: 52008: 32009: 22010: 12011: 12012: 32013: 22016: 12017: 12019: 22020: 12021: 12022: 22023: 12024: 12026 (partial year): 1
2007high 5 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWD

47in 2012

2007: 65 days median2008: 84 days median2012: 47 days median
2007high 84 (2008) · low 47 (2012)2026

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

Recalls per year · KWD

10in 2022

2008: 12014: 12016: 12022: 102026 (partial year): 1
2007high 10 (2022) · low 0 (2007)2026

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

Adverse event reports per year · KWD

8in 2025

2008: 22010: 32011: 32012: 12013: 42014: 32015: 102016: 72017: 102018: 82019: 192020: 42021: 22022: 102023: 272024: 1332025: 8
2007high 133 (2024) · low 0 (2007)2025

MAUDE reports naming product code KWD, 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
200756500
200838412
20092—00
20101—03
20111—03
201234701
20132—04
20140—13
20150—010
20161—17
20171—010
20180—08
20192—019
20201—04
20211—02
20222—1010
20231—027
20241—0133
20250—08
20261—1—

What is it indicated for?

The Cannulated Metallic Toe Implant, as designed, has the following Indications for Use:

Hallux Limitus or Hallux Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing of Arthritic M-P Joints.

The material used to manufacture this prosthesis is implant-quality cobalt-chrome alloy ASTM F75. The implant may be cemented to the phalanx or press-fit without cement.

Indications for use as stated in the FDA 510(k) statement.

More from Vilex, Inc.

13 FDA decisions under this applicant name. See the company

  • K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014
  • K112837Vilex EZ-Staple (Memory Bone Fixation Staple)Vilex, Inc. · 2012
  • K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 20113 recalls
  • K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
  • K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007

Recent decisions in KWD

The KWD category page

  • K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc. · 2026
  • K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2024
  • K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity Medical · 2023
  • K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022
  • K201393restor3d MTP ImplantRestor3D, Inc. · 20221 recall

https://510kreport.com/device/K023684 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023684: Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023684

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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