Cleared Traditional

K843942 - HENNING MENISCAL SUTURE KIT

K843942 is an FDA 510(k) clearance for HENNING MENISCAL SUTURE KIT, manufactured by Stryker Corp.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K843942 · Stryker Corp. · Orthopedic device
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Apr 1985
Decision
188d
Days
Class 1
Risk

K843942 is an FDA 510(k) clearance for the HENNING MENISCAL SUTURE KIT. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on April 15, 1985 after a review of 188 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Stryker Corp. devices

FDA 510(k) Submission Details - K843942

510(k) Number K843942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1984
Decision Date April 15, 1985
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

LXH Device Classification - Class 1, General Controls

Product Code LXH Orthopedic Manual Surgical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LXH Orthopedic Manual Surgical Instrument

All 28
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K843942.
MICRODISCECTOMY CURRETTES
K882077 · Karlin Technology, Inc. · Jun 1988
PATELLAR TENDON GRAFT GUIDE
K880413 · Concept, Inc. · Mar 1988
ACROMED SPINAL SURGERY INSTRUMENTS
K860131 · Buckman Co., Inc. · Mar 1986
6.5MM HEX HANDLE
K841969 · Stainless Mfg., Inc. · Jun 1984
CAMELBACK HANDLE-K841969-LABELING
K841970 · Stainless Mfg., Inc. · Jun 1984
MENISCAL SUTURING SYSTEM
K833943 · Dyonics, Inc. · Feb 1984