BRM TOOL Screws, BIOPLAN Subtalar Implant— 510(k) K222820

Name: FDA 510(k) clearance K222820
Creator: U.S. Food and Drug Administration
Published: 2022-12-16

Substantially Equivalent

Brm Extremities

FDA 510(k) clearance K222820 for BRM TOOL Screws, BIOPLAN Subtalar Implant, Substantially Equivalent on 2022-12-16. Applicant: Brm Extremities. Device class: 2.

Clearance details

Applicant: Brm Extremities
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2022-09-19
Decision date: 2022-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Civate, IT

Download summary PDF View on FDA.gov ↗

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K260106 — OsteoCoil GT Active Compression System2026-08-24
K262344 — Large Compression Screws2026-08-12
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22

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K191966 — NewPrim System2020-02-13

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.