Cleared Traditional

K951472 - LMT BONE ANCHOR

K951472 is an FDA 510(k) clearance for LMT BONE ANCHOR, manufactured by Li Medical Technologies, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K951472 · Li Medical Technologies, Inc. · Orthopedic device
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Jul 1995
Decision
95d
Days
Class 2
Risk

K951472 is an FDA 510(k) clearance for the LMT BONE ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Li Medical Technologies, Inc. (Shelton, US). The FDA issued a Cleared decision on July 3, 1995 after a review of 95 days - within the typical 510(k) review window.

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: 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 Li Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K951472

510(k) Number K951472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1995
Decision Date July 03, 1995
Days to Decision 95 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 122d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 774
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K951472.
ORTHOPEDIC SCREW FIXATION
K932350 · Osteomed Corp. · Jul 1995
HARPOON SUTURE ANCHORS
K943806 · Biomet, Inc. · Jul 1995
LMT BONE ANCHOR
K951233 · Li Medical Technologies, Inc. · Jul 1995
K4 BONE SCREW SYSTEM
K950704 · Kinetikos Medical, Inc. · Jun 1995
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
K950652 · Osteotech, Inc. · Jun 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304 · Synthes (Usa) · Jun 1995