Cleared Traditional

K903811 - ACE CANNULATED CORTICAL BONE SCREW

K903811 is an FDA 510(k) clearance for ACE CANNULATED CORTICAL BONE SCREW, manufactured by Ace Medical Co.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K903811 · Ace Medical Co. · Orthopedic device
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Oct 1990
Decision
57d
Days
Class 2
Risk

K903811 is an FDA 510(k) clearance for the ACE CANNULATED CORTICAL BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ace Medical Co. (Concord, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 57 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 Ace Medical Co. devices

FDA 510(k) Submission Details - K903811

510(k) Number K903811 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 20, 1990
Decision Date October 16, 1990
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 734
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K903811.
CORTICAL BONE SCREW (EUROPEAN STYLE)
K905357 · O'Tec Corp. · Jan 1991
CANCELLOUS SCREW
K905358 · O'Tec Corp. · Jan 1991
ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
K903810 · Ace Medical Co. · Oct 1990
CANCELLOUS SCREW
K903253 · Onyx Medical Corp. · Aug 1990
U.S. TYPE CRUCIATE SLOT BONE SCREW
K903254 · Onyx Medical Corp. · Aug 1990
CORTICAL BONE SCREW (EUROPEAN STYLE)
K903255 · Onyx Medical Corp. · Aug 1990