Cleared Traditional

K897141 - SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO

K897141 is an FDA 510(k) clearance for SLOT STAPLES AND ADAPTOR FOR ZIELKE SPI..., manufactured by Stuart. The device is a Class 2 Orthopedic device with product code JDN cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K897141 · Stuart · Orthopedic device
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Jun 1990
Decision
176d
Days
Class 2
Risk

K897141 is an FDA 510(k) clearance for the SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO. Classified as Implant, Fixation Device, Spinal (product code JDN), Class II - Special Controls.

Submitted by Stuart (Greensburg, US). The FDA issued a Cleared decision on June 21, 1990 after a review of 176 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K897141

510(k) Number K897141 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 27, 1989
Decision Date June 21, 1990
Days to Decision 176 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 122d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDN Device Classification - Class 2, Special Controls

Product Code JDN Implant, Fixation Device, Spinal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.