INSTINCT JAVA SYSTEM— 510(k) K122592

Name: FDA 510(k) clearance K122592
Creator: U.S. Food and Drug Administration
Published: 2013-01-04

Substantially Equivalent

Zimmer Spine

FDA 510(k) clearance K122592 for INSTINCT JAVA SYSTEM, Substantially Equivalent on 2013-01-04. Applicant: Zimmer Spine. Device class: 2.

Clearance details

Applicant: Zimmer Spine
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2012-08-24
Decision date: 2013-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K162143 — FixxSure® X-Link2016-09-23
K161151 — Spinal fixation system2016-09-21
K162189 — ANAX 5.5 Spinal System2016-08-30

More clearances from Zimmer Spine

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K123552 — INSTINCT JAVA SYSTEM2013-04-19
K113270 — INSTINCT JAVA SYSTEM2011-12-16
K111301 — INSTINCT JAVA SYSTEM2011-08-26
K110348 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEM2011-08-11

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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 K122592

K-number listed on FDA's recall record

Z-1190-2016 — Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.Class II·Terminated·Zimmer Spine, Inc.·20160212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122592.

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