MEMORY METAL STAPLES, EASYCLIP— 510(k) K122113

Name: FDA 510(k) clearance K122113
Creator: U.S. Food and Drug Administration
Published: 2013-03-12

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K122113 for MEMORY METAL STAPLES, EASYCLIP, Substantially Equivalent on 2013-03-12. Applicant: Stryker Corp.. Device class: 2.

Clearance details

Applicant: Stryker Corp.
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2012-07-17
Decision date: 2013-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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K243742 — Arthrex DynaNite Nitinol Staples2025-01-31
K243658 — TMC Compression Implant System2024-12-26

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K230045 — HipCheck2023-09-29
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K143399 — Stryker Footed Attachments and Cutting Accessories2015-05-08
K143320 — Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments2015-04-23

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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 K122113

K-number listed on FDA's recall record

Z-0457-2021 — Osteosynthesis Compression Staple EasyClipClass II·Ongoing·Stryker GmbH·20200925

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122113.

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