ARTHROTEK INTERFERENCE SCREW— 510(k) K982497

Name: FDA 510(k) clearance K982497
Creator: U.S. Food and Drug Administration
Published: 1998-10-16

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K982497 for ARTHROTEK INTERFERENCE SCREW, Substantially Equivalent on 1998-10-16. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1998-07-20
Decision date: 1998-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22

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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 →

Recalls naming K982497

K-number listed on FDA's recall record

Z-3176-2018 — Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612Class II·Terminated·Zimmer Biomet, Inc.·20180720
Z-3177-2018 — Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629Class II·Terminated·Zimmer Biomet, Inc.·20180720
Z-1734-2018 — Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.Class II·Terminated·Zimmer Biomet, Inc.·20180328
Z-1739-2018 — Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.Class II·Terminated·Zimmer Biomet, Inc.·20180328
Z-1945-2015 — Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment proceduresClass II·Terminated·Biomet, Inc.·20150603

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982497.

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