Cleared Traditional

K894124 - OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS

K894124 is an FDA 510(k) clearance for OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K894124 · Osteonics Corp. · Orthopedic device
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Sep 1989
Decision
91d
Days
Class 2
Risk

K894124 is an FDA 510(k) clearance for the OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on September 11, 1989 after a review of 91 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K894124

510(k) Number K894124 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 12, 1989
Decision Date September 11, 1989
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 979
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K894124.
CORTICAL SCREW
K895217 · Orthopedic Systems, Inc. · Sep 1989
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM
K895218 · Orthopedic Systems, Inc. · Sep 1989
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
K895219 · Orthopedic Systems, Inc. · Sep 1989
DEPUY CANNULATED BONE SCREW
K893512 · Depuy, Inc. · Aug 1989
VECSEI EXPANDING SCREW
K892925 · Howmedica Corp. · Aug 1989
REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW
K892214 · Ace Medical Co. · Jun 1989