Cleared Traditional

OMNIFIT BONE SCREW (K873251) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K873251 · Osteonics Corp. · Orthopedic device
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Sep 1987
Decision
32d
Days
Class 2
Risk

K873251 is an FDA 510(k) clearance for the OMNIFIT BONE SCREW. 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 18, 1987 after a review of 32 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 Osteonics Corp. devices

Submission Details

510(k) Number K873251 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 17, 1987
Decision Date September 18, 1987
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K873251.
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
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · Howmedica Corp. · Dec 1986
BONE SCREW
K831873 · W.L. Gore & Associates, Inc. · Aug 1983
SEIDEL INTRAMEDULLARY PLUG
K792205 · Howmedica Corp. · Dec 1979