Cleared Traditional

K991298 - BONE MULCH SCREW SYSTEM

K991298 is the FDA 510(k) clearance for BONE MULCH SCREW SYSTEM by Biomet, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K991298 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 1999
Decision
29d
Days
Class 2
Risk

K991298 is an FDA 510(k) clearance for the BONE MULCH SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 14, 1999 after a review of 29 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, Inc. devices

Submission Details

510(k) Number K991298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1999
Decision Date May 14, 1999
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 620
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K991298.
BIORC ANCHOR
K990770 · Linvatec Corp. · Jul 1999
SPIN SNAP-OFF SCREW
K991477 · New Deal, S.A. · Jul 1999
BIO-INTERFERENCE SCREW
K990454 · Innovasive Devices, Inc. · Jul 1999
BOLD SCREW
K990622 · New Deal, S.A. · Apr 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776 · Aap Implantate AG · Apr 1999
STAYFUSE
K990804 · Pioneer Surgical Technology · Apr 1999