Cleared Traditional

K982155 - SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM

K982155 is an FDA 510(k) clearance for SHORT STRAIGHT-IN BONE SCREW FIXATION S..., manufactured by Influence, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K982155 · Influence, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
74d
Days
Class 2
Risk

K982155 is an FDA 510(k) clearance for the SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM. 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 Influence, Inc. (Washington, US). The FDA issued a Cleared decision on August 31, 1998 after a review of 74 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Influence, Inc. devices

FDA 510(k) Submission Details - K982155

510(k) Number K982155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1998
Decision Date August 31, 1998
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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 K982155.
INNOVASIVE TIBIAL FASTENER
K983056 · Innovasive Devices, Inc. · Oct 1998
KSEA FLIPPTACK
K982571 · KARL STORZ Endoscopy-America, Inc. · Sep 1998
SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
K982169 · Doctor'S Research Group, Inc. · Sep 1998
5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235
K974847 · Arthrex, Inc. · Aug 1998
MENISCAL REPAIR DEVICE
K981692 · Linvatec Corp. · Jul 1998
WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE
K981967 · Arthrotek/Biomet, Inc. · Jul 1998