Cleared Traditional

K010633 - RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM

K010633 is an FDA 510(k) clearance for RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM, manufactured by Mitek Products. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K010633 · Mitek Products · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
68d
Days
Class 2
Risk

K010633 is an FDA 510(k) clearance for the RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Mitek Products (Norwood, US). The FDA issued a Cleared decision on May 9, 2001 after a review of 68 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.

FDA 510(k) Submission Details - K010633

510(k) Number K010633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2001
Decision Date May 09, 2001
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K010633.
DJ ORTHOPEDICS POST SCREW
K010594 · Dj Orthopedics, LLC · May 2001
MENISCUS ARROW SHEATH #CN1000A
K010554 · Bionx Implants, Inc. · May 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · Arthrex, Inc. · May 2001
DJ ORTHOPEDICS INTERFERENCE SCREW
K010595 · Dj Orthopedics, LLC · May 2001
SMARTSCREW MODEL 222006...227510
K003077 · Bionx Implants, Ltd. · Apr 2001
LACTOSORB 5.0 MM WASHER
K001581 · Biomet, Inc. · Mar 2001
K010633 · RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
Download PDF FDA Summary Mitek Products