JONES-FX FRACTURE SYSTEM— 510(k) K131620

Name: FDA 510(k) clearance K131620
Creator: U.S. Food and Drug Administration
Published: 2013-07-25

Substantially Equivalent

Instratek, Inc.

FDA 510(k) clearance K131620 for JONES-FX FRACTURE SYSTEM, Substantially Equivalent on 2013-07-25. Applicant: Instratek, Inc.. Device class: 2.

Clearance details

Applicant: Instratek, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2013-06-03
Decision date: 2013-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

view all

K261057 — ActivaScrew Cannulated COM2026-09-04
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

More clearances from Instratek, Inc.

view all

K133523 — STAPIX SUPERELASTIC IMPLANT BONE STAPLES2014-02-06
K120493 — MINI CANNULATED HEADED AND HEADLESS SCREW SET2012-05-17
K111032 — CMC CABLE FIX2011-08-31
K091763 — MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA60002009-08-14
K082384 — HAV-LOK BUNION CORRECTION SYSTEM2008-12-08

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.