OsteoCoil GT Active Compression System— 510(k) K260106

Name: FDA 510(k) clearance K260106
Creator: U.S. Food and Drug Administration
Published: 2026-08-24

Substantially Equivalent

Flower Orthopedics Corporation DBA Conventus Flower Orthoped

FDA 510(k) clearance K260106 for OsteoCoil GT Active Compression System, Substantially Equivalent on 2026-08-24. Applicant: Flower Orthopedics Corporation DBA Conventus Flower Orthoped. Device class: 2.

Clearance details

Applicant: Flower Orthopedics Corporation DBA Conventus Flower Orthoped
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-01-14
Decision date: 2026-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

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K262344 — Large Compression Screws2026-08-12
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22
K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System2026-06-25
K253108 — VEOFIX Snap Off Screw2026-06-05

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.