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Adjustable cutting guide adaptor
Model Knee+ · PIXEE MEDICAL · DI 03760297030445
SBF — Orthopedic Augmented Reality · Class II · 21 CFR 882.4560
UDILibrary device dossier · generated 2026-09-12 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2020-08
0
3
2021-09
0
1
2021-12
0
2
2022-01
0
2
2022-07
0
1
2022-08
0
1
2022-11
0
2
2022-12
0
2
2023-01
0
2
2023-04
0
2
2023-05
0
2
2023-07
0
2
2023-08
0
4
2023-09
0
2
2023-10
0
1.5
2023-12
0
4
2024-01
0
1
2024-02
0
1
2024-04
0
1
2025-03
0
1
2025-08
0
2
2025-09
0
1
2026-03
0
1
This device (reports/month)Average device in SBF (reports/device/month)