Cleared Traditional

K990295 - BONE ANCHOR SYSTEM III (BAS III)

K990295 is an FDA 510(k) clearance for BONE ANCHOR SYSTEM III (BAS III), manufactured by Boston Scientific Corp. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K990295 · Boston Scientific Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
35d
Days
Class 2
Risk

K990295 is an FDA 510(k) clearance for the BONE ANCHOR SYSTEM III (BAS III). 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 Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 5, 1999 after a review of 35 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K990295

510(k) Number K990295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1999
Decision Date March 05, 1999
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 438
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K990295.
TALON ANCHOR SNAP-PAK
K993261 · Mitek Products · Dec 1999
RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
K992458 · Innovasive Devices, Inc. · Oct 1999
RC TACK
K992377 · Innovasive Devices, Inc. · Oct 1999
IMPLEX SCREW AND WASHER SYSTEM
K982751 · Implex Corp. · Feb 1999
INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER
K983560 · Innovasive Devices, Inc. · Jan 1999
STRYKER WEDGE SUTURE ANCHOR
K983557 · Stryker Endoscopy · Dec 1998