Cleared Traditional

K931652 - ACE 6.5 MM BONE SCREW

K931652 is an FDA 510(k) clearance for ACE 6.5 MM 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 388-day FDA review.

K931652 · Ace Medical Co. · Orthopedic device
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Apr 1994
Decision
388d
Days
Class 2
Risk

K931652 is an FDA 510(k) clearance for the ACE 6.5 MM BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ace Medical Co. (Los Angeles, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 388 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 Ace Medical Co. devices

FDA 510(k) Submission Details - K931652

510(k) Number K931652 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 05, 1993
Decision Date April 28, 1994
Days to Decision 388 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
266d slower than avg
Panel avg: 122d · This submission: 388d
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 K931652.
TITANIUM ALLOY BONE SCREWS
K940207 · Aesculap, Inc. · Jul 1994
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K933719 · Linvatec Corp. · May 1994
CANNULATED CANCELLOUS SCREW
K931680 · Onyx Medical Corp. · May 1994
CANNULATED NAVICULAR SCREW
K931681 · Onyx Medical Corp. · Apr 1994
CORTICAL BONE SCREW
K931790 · Onyx Medical Corp. · Apr 1994
CANCELLOUS BONE SCREW
K934615 · Onyx Medical Corp. · Apr 1994