Cleared Traditional

K850024 - ORTHOPEDIC IMPLANT SCREWS

K850024 is an FDA 510(k) clearance for ORTHOPEDIC IMPLANT SCREWS, manufactured by Kirkstil Corp., Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K850024 · Kirkstil Corp., Inc. · Orthopedic device
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May 1985
Decision
137d
Days
Class 2
Risk

K850024 is an FDA 510(k) clearance for the ORTHOPEDIC IMPLANT SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Kirkstil Corp., Inc. (St. Louis, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 137 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.

FDA 510(k) Submission Details - K850024

510(k) Number K850024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1985
Decision Date May 20, 1985
Days to Decision 137 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 122d · This submission: 137d
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 1064
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K850024.
LINK CANCELLOUS SCREWS
K854826 · Link America, Inc. · Dec 1985
LINK CORTICAL SCREWS
K854827 · Link America, Inc. · Dec 1985
FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER
K852026 · Warsaw Orthopedic, Inc. · May 1985
INTERMEDICS BONE SCREW
K850770 · Intermedics Orthopedics · Apr 1985
BONE SCREW
K831873 · W.L. Gore & Associates, Inc. · Aug 1983
SEIDEL INTRAMEDULLARY PLUG
K792205 · Howmedica Corp. · Dec 1979
K850024 · ORTHOPEDIC IMPLANT SCREWS
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