Cleared Traditional

K953350 - MLI INTERFERENCE SCREW

K953350 is an FDA 510(k) clearance for MLI INTERFERENCE SCREW, manufactured by Medicinelodge, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K953350 · Medicinelodge, Inc. · Orthopedic device
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Jan 1996
Decision
197d
Days
Class 2
Risk

K953350 is an FDA 510(k) clearance for the MLI INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medicinelodge, Inc. (Logan, US). The FDA issued a Cleared decision on January 30, 1996 after a review of 197 days - an extended review 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: 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 Medicinelodge, Inc. devices

FDA 510(k) Submission Details - K953350

510(k) Number K953350 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 17, 1995
Decision Date January 30, 1996
Days to Decision 197 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
75d slower than avg
Panel avg: 122d · This submission: 197d
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 787
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K953350.
NORTHO BONE SCREW
K925872 · Northo Orthopedics · Mar 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837 · Wrightmedicaltechnologyinc · Mar 1996
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246 · Acufex Microsurgical, Inc. · Feb 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303 · Arthrex, Inc. · Jan 1996
FIXANO D.D.S. (DOUBLE SLIDING SCREW)
K954757 · Ferguson Medical · Jan 1996
SUPER SCREW 3.5 MM
K954330 · Osteomed Corp. · Dec 1995