Cleared Traditional

K911717 - ADG INTRAMEDULLARY BONE PLUG - VENTED

K911717 is an FDA 510(k) clearance for ADG INTRAMEDULLARY BONE PLUG - VENTED, manufactured by American Design Group, Inc.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K911717 · American Design Group, Inc. · Orthopedic device
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Sep 1991
Decision
140d
Days
Class 2
Risk

K911717 is an FDA 510(k) clearance for the ADG INTRAMEDULLARY BONE PLUG - VENTED. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by American Design Group, Inc. (Concord, US). The FDA issued a Cleared decision on September 4, 1991 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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.

View all American Design Group, Inc. devices

FDA 510(k) Submission Details - K911717

510(k) Number K911717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date September 04, 1991
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZN Device Classification - Class 2, Special Controls

Product Code LZN Cement Obturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - LZN Cement Obturator

All 28
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K911717.
UNIVERSAL BONE CEMENT KIT
K931540 · Biodynamic Technologies, Inc. · Jan 1994
RESORABPLUG
K920118 · Sofamor Danek Mfg., Inc. · Feb 1993
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL
K923909 · Orthomet, Inc. · Nov 1992
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG
K890326 · Howmedica Corp. · Feb 1989
SILASTIC INFLATABLE BONE PLUG H.P.
K853186 · Dow Corning Corp. Healthcare Industries Materials · Sep 1985
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
K852449 · Howmedica Corp. · Aug 1985