Cleared Traditional

K874913 - ORTHOMET PIN SYSTEM

K874913 is an FDA 510(k) clearance for ORTHOMET PIN SYSTEM, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

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

FDA 510(k) Submission Details - K874913

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
Combination Product No
PCCP Authorized No
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.

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 107
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K874913.
STEINMAN PIN
K903265 · Onyx Medical Corp. · Jul 1990
BIOFIX* BIODEGRADABLE FIXATION ROD
K890902 · Davis & Geck, Inc. · Nov 1989
ACE BEADED K-WIRES ACE OLIVE WIRES
K895079 · Buckman Co., Inc. · Sep 1989
PDS (POLYDIOXANON) ABSORBABLE PIN
K864912 · Johnson & Johnson Professionals, Inc. · Jul 1987
STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS
K863734 · Micro-Aire Surgical Instruments, Inc. · Oct 1986
CANNULATED LAG SCREWS
K863119 · Downs Surgical , Ltd. · Sep 1986