Cleared Traditional

K892214 - REVERSE CUTTING CANNULATED CANCELLOUS B...

K892214 is an FDA 510(k) clearance for REVERSE CUTTING CANNULATED CANCELLOUS B..., 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 80-day FDA review.

K892214 · Ace Medical Co. · Orthopedic device
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Jun 1989
Decision
80d
Days
Class 2
Risk

K892214 is an FDA 510(k) clearance for the REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ace Medical Co. (Martinez, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 80 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 - K892214

510(k) Number K892214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date June 22, 1989
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 K892214.
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
K894124 · Osteonics Corp. · Sep 1989
DEPUY CANNULATED BONE SCREW
K893512 · Depuy, Inc. · Aug 1989
VECSEI EXPANDING SCREW
K892925 · Howmedica Corp. · Aug 1989
ACUFEX INTERFERENCE SCREW AND SCREWDRIVER
K883910 · Acufex Microsurgical, Inc. · Oct 1988
ACE CANCELLOUS BONE SCREW
K882831 · Buckman Co., Inc. · Aug 1988
INTERFERENCE SCREW
K874676 · Concept, Inc. · Mar 1988