Cleared Traditional

ORTHOMET PIN SYSTEM (K874913) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874913 · Orthomet, Inc. · Orthopedic device
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Jan 1988
Decision
35d
Days
Class 2
Risk

K874913 is an FDA 510(k) clearance for the ORTHOMET PIN SYSTEM. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 7, 1988 after a review of 35 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 Orthomet, Inc. devices

Submission Details

510(k) Number K874913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1987
Decision Date January 07, 1988
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 69
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K874913.
LACTOSORB BONE PIN
K953194 · Biomet, Inc. · Oct 1995
SPETZLER PIN
K954001 · Howmedica Corp. · Oct 1995
SPETZLER PIN
K945639 · Howmedica Corp. · Apr 1995
PDS (POLYDIOXANON) ABSORBABLE PIN
K864912 · Johnson & Johnson Professionals, Inc. · Jul 1987
FIXATION PINS
K833952 · Ethicon, Inc. · Feb 1984
PIN RETRACTORS
K771418 · Stryker Corp. · Sep 1977