Cleared Traditional

K992458 - RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454

K992458 is an FDA 510(k) clearance for RC MULTISUTURE BONE ANCHOR, manufactured by Innovasive Devices, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K992458 · Innovasive Devices, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
83d
Days
Class 2
Risk

K992458 is an FDA 510(k) clearance for the RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454. 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 Innovasive Devices, Inc. (Marlboro, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 83 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 Innovasive Devices, Inc. devices

FDA 510(k) Submission Details - K992458

510(k) Number K992458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1999
Decision Date October 14, 1999
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 K992458.
STAPLETAC2 BONE ANCHOR SYSTEM
K000279 · American Medical Systems, Inc. · Mar 2000
ACUMED SUTURE ANCHOR
K993657 · Acu Med, Inc. · Jan 2000
TALON ANCHOR SNAP-PAK
K993261 · Mitek Products · Dec 1999
RC TACK
K992377 · Innovasive Devices, Inc. · Oct 1999
MULTITAK SS BUTTONS
K990156 · Bonutti Research · Mar 1999
BONE ANCHOR SYSTEM III (BAS III)
K990295 · Boston Scientific Corp · Mar 1999