Cleared Traditional

K100271 - VARI AX DISTAL RADIUS LINE EXTENSIONS O...

K100271 is the FDA 510(k) clearance for VARI AX DISTAL RADIUS LINE EXTENSIONS O... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K100271 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
105d
Days
Class 2
Risk

K100271 is an FDA 510(k) clearance for the VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on May 14, 2010 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K100271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2010
Decision Date May 14, 2010
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 906
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K100271.
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240 · DePuy Orthopaedics, Inc. · Jul 2010
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708
K101421 · DePuy Orthopaedics, Inc. · Jun 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240 · OrthoPediatrics Corp. · May 2010
VARIAX ELBOW SYSTEM
K101056 · Howmedica Osteonics Corp. · May 2010
SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
K092812 · Synthes (Usa) · May 2010
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
K093978 · Exactech, Inc. · May 2010