Cleared Traditional

K953194 - LACTOSORB BONE PIN

K953194 is an FDA 510(k) clearance for LACTOSORB BONE PIN, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K953194 · Biomet, Inc. · Orthopedic device
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Oct 1995
Decision
113d
Days
Class 2
Risk

K953194 is an FDA 510(k) clearance for the LACTOSORB BONE PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 31, 1995 after a review of 113 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K953194

510(k) Number K953194 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 10, 1995
Decision Date October 31, 1995
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 176
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K953194.
STEINMAN PIN
K960483 · American Medical Specialties, Inc. · Apr 1996
STERILE KIRSCHNER WIRES AND STEINMANN PINS
K960385 · Depuy, Inc. · Mar 1996
HOWMEDICA BIOABSORBABLE PIN
K955806 · Howmedica, Inc. · Feb 1996
SPETZLER PIN
K954001 · Howmedica Corp. · Oct 1995
FIXATION PINS/WIRES
K943856 · Acu Med, Inc. · Jul 1995
SPETZLER PIN
K945639 · Howmedica Corp. · Apr 1995