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Cannulated 1st MPJ Hemi Implant

Model CHI-2CH · VILEX LLC · DI 00841731106179

KWD — Prosthesis, Toe, Hemi-, Phalangeal · Class II · 21 CFR 888.3730

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12342019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 2.5/device2023-04: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3/device2023-10: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 4/device2024-05: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device06070502040607100205120406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0603
2019-0701
2022-0501
2023-0202.5
2023-0403
2023-0603
2023-0703
2023-1002
2024-0204
2024-0503
2024-1202
2026-0401
2026-0601
This device (reports/month)Average device in KWD (reports/device/month)

Regulatory clearances

  • K102401 SESE 2011-07-20 (k number procode)

Predicate lineage

K102401 — cites (transitively): K023684 (d1) — cited as predicate by K131187, K190543, K200951

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — VILEX LLC

  • Warning Letter 2018-01-10 Vilex in Tennessee, Inc.
  • NAI 2018-07-19 Vilex in Tennessee, Inc. · 0 citations
  • OAI 2017-08-25 Vilex in Tennessee, Inc. · 5 citations
  • VAI 2012-11-01 Vilex in Tennessee, Inc. · 7 citations
  • VAI 2010-09-01 Vilex in Tennessee, Inc. · 4 citations