Cleared Traditional

K810497 - BONE FIXACTION SCREW

K810497 is an FDA 510(k) clearance for BONE FIXACTION SCREW, manufactured by Serrano Intl.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K810497 · Serrano Intl. · Orthopedic device
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Mar 1981
Decision
15d
Days
Class 2
Risk

K810497 is an FDA 510(k) clearance for the BONE FIXACTION SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Serrano Intl. (Mchenry, US). The FDA issued a Cleared decision on March 11, 1981 after a review of 15 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 Serrano Intl. devices

FDA 510(k) Submission Details - K810497

510(k) Number K810497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1981
Decision Date March 11, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 122d · This submission: 15d
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 1017
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K810497.
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
HERBERT BONE SCREW
K792022 · Zimmer, Inc. · Oct 1979
ORTHOPEDIC DEVICES
K780235 · Biomet, Inc. · Feb 1978