Cleared Traditional

K983169 - POLYMER THREADED ANCHOR

K983169 is an FDA 510(k) clearance for POLYMER THREADED ANCHOR, manufactured by Orthopaedic Biosystems, Ltd.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K983169

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
Combination Product No
PCCP Authorized No
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.

MBI Device Classification - Class 2, Special Controls

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 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K983169.
INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER
K983560 · Innovasive Devices, Inc. · Jan 1999
STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM
K984200 · R. Thomas Grotz, M.D., Inc. · Jan 1999
STRYKER WEDGE SUTURE ANCHOR
K983557 · Stryker Endoscopy · Dec 1998
MITEK FASTIN RC ANCHOR
K983818 · Mitek Products · Nov 1998
INNOVASIVE TIBIAL FASTENER
K983056 · Innovasive Devices, Inc. · Oct 1998
KSEA FLIPPTACK
K982571 · KARL STORZ Endoscopy-America, Inc. · Sep 1998