Cleared Traditional

K931697 - FIXATION PIN

K931697 is an FDA 510(k) clearance for FIXATION PIN, manufactured by Orthologic Corp.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 401-day FDA review.

K931697 · Orthologic Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
401d
Days
Class 2
Risk

K931697 is an FDA 510(k) clearance for the FIXATION PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Orthologic Corp. (Phoenix, US). The FDA issued a Cleared decision on May 12, 1994 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

FDA 510(k) Submission Details - K931697

510(k) Number K931697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date May 12, 1994
Days to Decision 401 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 122d · This submission: 401d
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 205
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K931697.
K-WIRES AND STEINMANN PINS
K941434 · Omega Surgical Instruments, Inc. · Oct 1994
BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE
K925098 · Bioscience, Inc. · Jul 1994
ACUFEX SMOOTH AND THREADED PINS
K931836 · Acufex Microsurgical, Inc. · Jun 1994
BAUMER PINS
K930969 · Baumer Ortopedia , Ltd. · Mar 1994
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · Osteomed Corp. · Mar 1994
TAVA K-WIRE
K940109 · Tava Surgical Instruments · Feb 1994
K931697 · FIXATION PIN
Download PDF FDA Summary Orthologic Corp.