Cleared Traditional

K992301 - REUNITE SCREWS

K992301 is the FDA 510(k) clearance for REUNITE SCREWS by Biomet Manufacturing, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K992301 · Biomet Manufacturing, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
55d
Days
Class 2
Risk

K992301 is an FDA 510(k) clearance for the REUNITE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 1, 1999 after a review of 55 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 Biomet Manufacturing, Inc. devices

Submission Details

510(k) Number K992301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1999
Decision Date September 01, 1999
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 567
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K992301.
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025 · Biomet, Inc. · Oct 1999
BIOBUTTON
K990194 · Linvatec Corp. · Sep 1999
MODUS SYSTEM SELF-DRILLING SCREWS
K992106 · Medartis AG · Sep 1999
BIORC ANCHOR
K990770 · Linvatec Corp. · Jul 1999
BIO-INTERFERENCE SCREW
K990454 · Innovasive Devices, Inc. · Jul 1999
BONE MULCH SCREW SYSTEM
K991298 · Biomet, Inc. · May 1999