Cleared Traditional

K010594 - DJ ORTHOPEDICS POST SCREW

K010594 is an FDA 510(k) clearance for DJ ORTHOPEDICS POST SCREW, manufactured by Dj Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010594 · Dj Orthopedics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
90d
Days
Class 2
Risk

K010594 is an FDA 510(k) clearance for the DJ ORTHOPEDICS POST SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Dj Orthopedics, LLC (Vista, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 90 days - within the typical 510(k) review window.

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: 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 Dj Orthopedics, LLC devices

FDA 510(k) Submission Details - K010594

510(k) Number K010594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2001
Decision Date May 29, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 880
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K010594.
PLUS CANCELLOUS BONE SCREWS
K011719 · Plus Orthopedics · Jul 2001
MODIFICATION TO THE BOLD SCREW
K011262 · New Deal, S.A. · Jun 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783 · Osteomed Corp. · May 2001
MENISCUS ARROW SHEATH #CN1000A
K010554 · Bionx Implants, Inc. · May 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · Arthrex, Inc. · May 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · Mitek Products · May 2001