Cleared Traditional

K852026 - FEMORAL PROXIMAL DIAGNOSAL SCREW

K852026 is an FDA 510(k) clearance for FEMORAL PROXIMAL DIAGNOSAL SCREW, manufactured by Warsaw Orthopedic, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K852026 · Warsaw Orthopedic, Inc. · Orthopedic device
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May 1985
Decision
14d
Days
Class 2
Risk

K852026 is an FDA 510(k) clearance for the FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 22, 1985 after a review of 14 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 Warsaw Orthopedic, Inc. devices

FDA 510(k) Submission Details - K852026

510(k) Number K852026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1985
Decision Date May 22, 1985
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K852026.
CANCELLOUS BONE SCREW
K864626 · Dow Corning Wright · Dec 1986
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
K862230 · Buckman Co., Inc. · Aug 1986
ACROMED CANCELLOUS BONE SCREW
K860017 · Buckman Co., Inc. · Feb 1986
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