Cleared Traditional

K792205 - SEIDEL INTRAMEDULLARY PLUG

K792205 is the FDA 510(k) clearance for SEIDEL INTRAMEDULLARY PLUG by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K792205 · Howmedica Corp. · Orthopedic device
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Dec 1979
Decision
34d
Days
Class 2
Risk

K792205 is an FDA 510(k) clearance for the SEIDEL INTRAMEDULLARY PLUG. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979 after a review of 34 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 Howmedica Corp. devices

Submission Details

510(k) Number K792205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1979
Decision Date December 06, 1979
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K792205.
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
HERBERT BONE SCREW
K792022 · Zimmer, Inc. · Oct 1979
ORTHOPEDIC DEVICES
K780235 · Biomet, Inc. · Feb 1978
SCREW, WADSWORTH OLECRANON
K770035 · Orthopedic Equipment Co., Inc. · Jan 1977