Cleared Abbreviated

K981755 - LM ANCHOR

K981755 is an FDA 510(k) clearance for LM ANCHOR, manufactured by Li Medical Technologies, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Abbreviated 510(k) pathway after a 56-day FDA review.

K981755 · Li Medical Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
56d
Days
Class 2
Risk

K981755 is an FDA 510(k) clearance for the LM 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 July 13, 1998 after a review of 56 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Li Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K981755

510(k) Number K981755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date July 13, 1998
Days to Decision 56 days
Submission Type Abbreviated
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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

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 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K981755.
MENISCAL REPAIR DEVICE
K981692 · Linvatec Corp. · Jul 1998
WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE
K981967 · Arthrotek/Biomet, Inc. · Jul 1998
ANSPACH SUTURE ANCHOR
K981688 · The Anspach Effort, Inc. · Jul 1998
LM ANCHOR
K981764 · Li Medical Technologies, Inc. · Jul 1998
INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
K981193 · Innovasive Devices, Inc. · Jun 1998
DEPUY ORTHOTECH CATERA SUTURE ANCHOR
K980595 · DePuy Orthopaedics, Inc. · May 1998