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Biocore9 Femoral Resurfacing Component
Model Femoral Resurfacing Component - 39.5 mm · Biocore9, LLC · DI 00810068850383
KXA — Prosthesis, Hip, Femoral, Resurfacing · Class II · 21 CFR 888.3400
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-03
0
2
2019-07
0
3
2019-09
0
6
2019-12
0
1
2020-02
0
3
2020-07
0
2.5
2020-08
0
2
2020-10
0
3
2020-11
0
3
2020-12
0
3
2021-02
0
3
2021-04
0
2
2021-05
0
3
2021-08
0
3
2021-09
0
3
2022-02
0
3
2022-05
0
3.5
2022-10
0
4.5
2024-04
0
3
2026-06
0
2
This device (reports/month)Average device in KXA (reports/device/month)
Regulatory clearances
K201219 SESE 2021-01-19 (k number procode)
Predicate lineage
K201219 — cites (transitively): K904870 (d1) — cited as predicate by K212761
Lineage extracted from public 510(k) summary text (heuristic).