Cleared Traditional

K982571 - KSEA FLIPPTACK

K982571 is the FDA 510(k) clearance for KSEA FLIPPTACK by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K982571 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
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Sep 1998
Decision
60d
Days
Class 2
Risk

K982571 is an FDA 510(k) clearance for the KSEA FLIPPTACK. 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 KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 60 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K982571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1998
Decision Date September 22, 1998
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 412
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K982571.
INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER
K983560 · Innovasive Devices, Inc. · Jan 1999
STRYKER WEDGE SUTURE ANCHOR
K983557 · Stryker Endoscopy · Dec 1998
INNOVASIVE TIBIAL FASTENER
K983056 · Innovasive Devices, Inc. · Oct 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
ANSPACH SUTURE ANCHOR
K981688 · The Anspach Effort, Inc. · Jul 1998