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restor3d MTP

Model 1103-161420 · Restor3d, Inc. · DI 00840097505237

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

UDILibrary device dossier · generated 2026-09-15 · 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

  • K201393 SESE 2022-05-25 (k number procode)

Predicate lineage

K201393 — cites (transitively): K090127 (d1) — cited as predicate by K240591

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

Manufacturer compliance record — Restor3d, Inc.

  • Warning Letter 2019-12-10 Conformis Inc.
  • VAI 2026-01-13 Conformis Inc. · 1 citations
  • VAI 2024-06-14 restor3d Inc. · 7 citations
  • VAI 2024-06-14 restor3d Inc. · 7 citations
  • VAI 2023-05-12 restor3d Inc. · 3 citations
  • VAI 2023-05-12 restor3d Inc. · 3 citations
  • NAI 2021-07-08 Conformis Inc. · 0 citations
  • OAI 2019-09-20 Conformis Inc. · 4 citations
  • VAI 2015-09-14 Conformis Inc. · 3 citations