Cleared Traditional

K840242 - POLY PLUG CEMENT RESTRICTOR

K840242 is an FDA 510(k) clearance for POLY PLUG CEMENT RESTRICTOR, manufactured by Latham Manufacturer. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K840242 · Latham Manufacturer · Orthopedic device
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May 1984
Decision
131d
Days
Class 2
Risk

K840242 is an FDA 510(k) clearance for the POLY PLUG CEMENT RESTRICTOR. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Latham Manufacturer (Walker, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K840242

510(k) Number K840242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1984
Decision Date May 30, 1984
Days to Decision 131 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDS Device Classification - Class 2, Special Controls

Product Code JDS Nail, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDS Nail, Fixation, Bone

All 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K840242.
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
K914453 · Synthes (Usa) · Feb 1992
HUMERAL LOCKING NAIL SYSTEM
K883882 · Howmedica Corp. · Jan 1989
TRACER HIP PINNING SYSTEM
K884406 · De Medica Mfg., Inc. · Nov 1988
INTRAMEDULLARY BONE PLUG
K832328 · Kirschner Medical Corp. · Oct 1983
SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)
K800898 · Dow Corning Corp. Healthcare Industries Materials · May 1980
FUSON BONE PLUG, RADIOPAQUE
K800142 · Zimmer, Inc. · Feb 1980
K840242 · POLY PLUG CEMENT RESTRICTOR
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