Cleared Traditional

K983169 - POLYMER THREADED ANCHOR

K983169 is the FDA 510(k) clearance for POLYMER THREADED ANCHOR by Orthopaedic Biosystems, Ltd.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K983169 · Orthopaedic Biosystems, Ltd. · Orthopedic device
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Dec 1998
Decision
97d
Days
Class 2
Risk

K983169 is an FDA 510(k) clearance for the POLYMER THREADED ANCHOR. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Orthopaedic Biosystems, Ltd. (Scottsdale, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 97 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 Orthopaedic Biosystems, Ltd. devices

Submission Details

510(k) Number K983169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1998
Decision Date December 16, 1998
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 391
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