Cleared Traditional

K964500 - ACUMED TENSION BAND PIN

K964500 is an FDA 510(k) clearance for ACUMED TENSION BAND PIN, manufactured by Acu Med, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K964500 · Acu Med, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
31d
Days
Class 2
Risk

K964500 is an FDA 510(k) clearance for the ACUMED TENSION BAND PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on December 9, 1996 after a review of 31 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 Acu Med, Inc. devices

FDA 510(k) Submission Details - K964500

510(k) Number K964500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1996
Decision Date December 09, 1996
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
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 159
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K964500.
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM
K970733 · Synthes (Usa) · Apr 1997
FIXATION PIN OR ROD
K970036 · United States Surgical, A Division of Tyco Healthc · Mar 1997
BIORIGID NAIL TIBIA
K970013 · Aap GmbH and Co. Betriebs KG · Mar 1997
BLOCK STOP WIRES
K964087 · Ferguson Medical · Nov 1996
RMS K-WIRE
K963367 · Rms Div. · Oct 1996
KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
K961522 · Synvasive Technology, Inc. · Sep 1996