Cleared Traditional

K990353 - STAINLESS STEEL FIXATION PINS (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990353 · Bregma International Trading Company , Ltd. · Orthopedic device
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Jun 1999
Decision
116d
Days
Class 2
Risk

K990353 is an FDA 510(k) clearance for the STAINLESS STEEL FIXATION PINS. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Bregma International Trading Company , Ltd. (Saskatoon, Saskatchewan, CA). The FDA issued a Cleared decision on June 1, 1999 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

View all Bregma International Trading Company , Ltd. devices

Submission Details

510(k) Number K990353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1999
Decision Date June 01, 1999
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDW Pin, Fixation, Threaded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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.

Regulatory Peers - JDW Pin, Fixation, Threaded

All 93
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K990353.
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