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VSP Orthopedics

Model Autograft Tibia Template · 3D SYSTEMS, INC. · DI 00816847022194

PBF — Orthopaedic Surgical Planning And Instrument Guides · Class II · 21 CFR 888.3030

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.

12342019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 4/device2020-07: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 2.67/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device1112010709040506030607111205100508100811120304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1101
2019-1203
2020-0104
2020-0701
2020-0902
2021-0401
2021-0501
2021-0601
2022-0302
2022-0601
2022-0702.67
2022-1101
2022-1201
2023-0501
2023-1001
2024-0501
2024-0801
2024-1001
2025-0802
2025-1101
2025-1201
2026-0301
2026-0401
This device (reports/month)Average device in PBF (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K190044 — cited as predicate by K193432, K202019, K211076, K211244, K212237, K212815, K220706

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

Manufacturer compliance record — 3D SYSTEMS, INC.

  • NAI 2023-09-15 Medical Modeling, a 3D Systems Company · 0 citations
  • NAI 2021-06-15 Medical Modeling, a 3D Systems Company · 0 citations
  • NAI 2017-05-05 Medical Modeling, a 3D Systems Company · 0 citations
  • NAI 2015-06-03 3D Systems, Inc. · 0 citations
  • NAI 2014-04-25 Medical Modeling, a 3D Systems Company · 0 citations