Cleared Traditional

K960439 - LM BONE ANCHOR

K960439 is an FDA 510(k) clearance for LM BONE ANCHOR, manufactured by Li Medical Technologies, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K960439 · Li Medical Technologies, Inc. · Orthopedic device
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Apr 1996
Decision
78d
Days
Class 2
Risk

K960439 is an FDA 510(k) clearance for the LM BONE ANCHOR. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Li Medical Technologies, Inc. (Shelton, US). The FDA issued a Cleared decision on April 18, 1996 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Li Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K960439

510(k) Number K960439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1996
Decision Date April 18, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 496
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K960439.
STATAK SOFT TISSUE ATTACHMENT DEVICE
K962397 · Zimmer, Inc. · Aug 1996
LM ANCHOR OR OTHER PROPRIETARY NAME
K960825 · Li Medical Technologies, Inc. · Apr 1996
QUESTLOCK ACL FIXATOR
K954683 · Wrightmedicaltechnologyinc · Apr 1996
FASTAK SUTURE ANCHOR
K960516 · Arthrex, Inc. · Apr 1996
LM ANCHOR
K960448 · Li Medical Technologies, Inc. · Apr 1996
INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER
K954338 · Innovasive Devices, Inc. · Mar 1996