Cleared Traditional

K990194 - BIOBUTTON

K990194 is the FDA 510(k) clearance for BIOBUTTON by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K990194 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
239d
Days
Class 2
Risk

K990194 is an FDA 510(k) clearance for the BIOBUTTON. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 239 days - an extended review 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: 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 Linvatec Corp. devices

Submission Details

510(k) Number K990194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1999
Decision Date September 17, 1999
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K990194.
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945 · Smith & Nephew, Inc. · Nov 1999
BONE BULLET SUTURE ANCHOR
K991024 · Linvatec Corp. · Nov 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025 · Biomet, Inc. · Oct 1999
MODUS SYSTEM SELF-DRILLING SCREWS
K992106 · Medartis AG · Sep 1999
BIORC ANCHOR
K990770 · Linvatec Corp. · Jul 1999
BONE MULCH SCREW SYSTEM
K991298 · Biomet, Inc. · May 1999