Cleared Traditional

K941941 - BONE MULCH SCREW

K941941 is an FDA 510(k) clearance for BONE MULCH SCREW, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K941941 · Biomet, Inc. · Orthopedic device
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Feb 1995
Decision
287d
Days
Class 2
Risk

K941941 is an FDA 510(k) clearance for the BONE MULCH SCREW. 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 February 2, 1995 after a review of 287 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K941941

510(k) Number K941941 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 21, 1994
Decision Date February 02, 1995
Days to Decision 287 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 122d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K941941.
LINVATEC STASYS-PES FIXATION DEVICE
K934321 · Linvatec Corp. · May 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330 · Acu Med, Inc. · May 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426 · Arthrex, Inc. · Apr 1995
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213 · Howmedica Corp. · Dec 1994
CORTICAL BONE SCREW
K942340 · Acu Med, Inc. · Dec 1994
CANNULATED CANCELLOUS BONE SCREW
K942341 · Acu Med, Inc. · Dec 1994