Cleared Traditional

K844595 - ORTHOPEDIC CUSTOM SURGICAL KIT

K844595 is an FDA 510(k) clearance for ORTHOPEDIC CUSTOM SURGICAL KIT, manufactured by Xanmed Corp.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K844595 · Xanmed Corp. · Orthopedic device
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Aug 1985
Decision
268d
Days
Class 1
Risk

K844595 is an FDA 510(k) clearance for the ORTHOPEDIC CUSTOM SURGICAL KIT. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Xanmed Corp. (Washington, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 268 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 Xanmed Corp. devices

FDA 510(k) Submission Details - K844595

510(k) Number K844595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1984
Decision Date August 21, 1985
Days to Decision 268 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 122d · This submission: 268d
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 29
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K844595.
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
HENNING MENISCAL SUTURE KIT
K843942 · Stryker Corp. · Apr 1985
6.5MM HEX HANDLE
K841969 · Stainless Mfg., Inc. · Jun 1984
CAMELBACK HANDLE-K841969-LABELING
K841970 · Stainless Mfg., Inc. · Jun 1984