Cleared Special

K052901 - ARTHREX TENSIONLOK

K052901 is an FDA 510(k) clearance for ARTHREX TENSIONLOK, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 59-day FDA review.

K052901 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
59d
Days
Class 2
Risk

K052901 is an FDA 510(k) clearance for the ARTHREX TENSIONLOK. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 12, 2005 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arthrex, Inc. devices

FDA 510(k) Submission Details - K052901

510(k) Number K052901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2005
Decision Date December 12, 2005
Days to Decision 59 days
Submission Type Special
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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1250
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K052901.
DRLOCK DISTAL RADIUS VOLAR SYSTEM
K053182 · Orthohelix Surgical Designs, Inc. · Feb 2006
TRIMED BONE PLATES
K060041 · TriMed, Inc. · Feb 2006
NEXA BONE PLATE AND SCREW SYSTEM
K053408 · Nexa Orthopedics, Inc. · Dec 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683 · Synthes (Usa) · Dec 2005
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
K052624 · Inion , Ltd. · Nov 2005
COLLAGEN BONE HEALING PROTECTIVE SHEET
K052041 · Collagen Matrix, Inc. · Oct 2005