Cleared Traditional

K931524 - FULLY THREADED ALTA CANCELLOUS BONE SCREW

K931524 is the FDA 510(k) clearance for FULLY THREADED ALTA CANCELLOUS BONE SCREW by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K931524 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
340d
Days
Class 2
Risk

K931524 is an FDA 510(k) clearance for the FULLY THREADED ALTA CANCELLOUS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Howmedica Corp. devices

Submission Details

510(k) Number K931524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1993
Decision Date March 01, 1994
Days to Decision 340 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
218d slower than avg
Panel avg: 122d · This submission: 340d
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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K931524.
CORTICAL BONE SCREW
K931790 · Onyx Medical Corp. · Apr 1994
CANCELLOUS BONE SCREW
K934615 · Onyx Medical Corp. · Apr 1994
CANCELLOUS BONE SCREW
K934616 · Onyx Medical Corp. · Apr 1994
OREGON FIXATION SYSTEM INTERFERENCE SCREW
K932027 · Acu Med, Inc. · Feb 1994
CONCEPT CANNULATED INTEREFERENCE SCREW
K933352 · Linvatec Corp. · Feb 1994
M. KUROSAKA INTERFERENCE FIXATION SCREW
K933738 · Depuy, Inc. · Feb 1994