Cleared Traditional

K895079 - ACE BEADED K-WIRES ACE OLIVE WIRES

K895079 is the FDA 510(k) clearance for ACE BEADED K-WIRES ACE OLIVE WIRES by Buckman Co., Inc.. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K895079 · Buckman Co., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
30d
Days
Class 2
Risk

K895079 is an FDA 510(k) clearance for the ACE BEADED K-WIRES ACE OLIVE WIRES. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on September 13, 1989 after a review of 30 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K895079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1989
Decision Date September 13, 1989
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 101
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K895079.
K-WIRE
K903264 · Onyx Medical Corp. · Jul 1990
STEINMAN PIN
K903265 · Onyx Medical Corp. · Jul 1990
BIOFIX* BIODEGRADABLE FIXATION ROD
K890902 · Davis & Geck, Inc. · Nov 1989
ORTHOMET PIN SYSTEM
K874913 · Orthomet, Inc. · Jan 1988
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