Cleared Traditional

K964444 - QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM

K964444 is an FDA 510(k) clearance for QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM, manufactured by Rdh Medical. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K964444 · Rdh Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
278d
Days
Class 2
Risk

K964444 is an FDA 510(k) clearance for the QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Rdh Medical (Paso Robles, US). The FDA issued a Cleared decision on August 11, 1997 after a review of 278 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Rdh Medical devices

FDA 510(k) Submission Details - K964444

510(k) Number K964444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date August 11, 1997
Days to Decision 278 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
156d slower than avg
Panel avg: 122d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K964444.
MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL
K972692 · Zimmer, Inc. · Sep 1997
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
K972183 · Ace Medical Co. · Aug 1997
ALTA INTRAMEDULLARY ROD SYSTEM
K972108 · Howmedica Corp. · Aug 1997
ATLAS FRACTURE PROXIMAL HUMERAL NAIL
K971816 · Biomet, Inc. · Jul 1997
MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM
K971135 · Wrightmedicaltechnologyinc · Jun 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES
K970257 · Ferguson Medical · May 1997