Cleared Traditional

K880413 - PATELLAR TENDON GRAFT GUIDE

K880413 is an FDA 510(k) clearance for PATELLAR TENDON GRAFT GUIDE, manufactured by Concept, Inc.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K880413 · Concept, Inc. · Orthopedic device
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Mar 1988
Decision
32d
Days
Class 1
Risk

K880413 is an FDA 510(k) clearance for the PATELLAR TENDON GRAFT GUIDE. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 4, 1988 after a review of 32 days - a notably fast clearance 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: 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 Concept, Inc. devices

FDA 510(k) Submission Details - K880413

510(k) Number K880413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1988
Decision Date March 04, 1988
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
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 22
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K880413.
T-HANDLE HEX WRENCH
K903270 · Onyx Medical Corp. · Jul 1990
COHN TARGETEER
K891903 · Orthopedic Systems, Inc. · May 1989
TENSIOMETER
K883694 · W.L. Gore & Associates, Inc. · Nov 1988
ACROMED SPINAL SURGERY INSTRUMENTS
K860131 · Buckman Co., Inc. · Mar 1986
HENNING MENISCAL SUTURE KIT
K843942 · Stryker Corp. · Apr 1985
CRANE MENISCAL SUTURE SET
K834369 · Acufex Microsurgical, Inc. · Feb 1984