Cleared Traditional

K926047 - ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW

K926047 is an FDA 510(k) clearance for ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW, manufactured by Ace Orthopedic Manufacturing Co.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K926047 · Ace Orthopedic Manufacturing Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
120d
Days
Class 2
Risk

K926047 is an FDA 510(k) clearance for the ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ace Orthopedic Manufacturing Co. (Los Angeles, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 120 days - within the typical 510(k) review window.

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 Ace Orthopedic Manufacturing Co. devices

FDA 510(k) Submission Details - K926047

510(k) Number K926047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date March 31, 1993
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 122d · This submission: 120d
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 978
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K926047.
ACUTRACT
K930834 · Acu Med, Inc. · Jul 1993
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
K926579 · Techmedica, Inc. · Apr 1993
M3 LAG SCREW FIXATION SYSTEM
K924018 · Osteomed Corp. · Apr 1993
3.5MM UNIVERSAL COMPRESSION SCREW
K923477 · Howmedica Corp. · Mar 1993
ARTHREX CANNULATED INTERFERENCE SCREW
K915424 · Arthrex, Inc. · Feb 1993
ACUFEX FIXATION POST
K924514 · Acufex Microsurgical, Inc. · Oct 1992