Cleared Traditional

K102282 - THE VARIA FIBULA LOCKED PLATING SYSTEM ...

K102282 is the FDA 510(k) clearance for THE VARIA FIBULA LOCKED PLATING SYSTEM ... by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K102282 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
117d
Days
Class 2
Risk

K102282 is an FDA 510(k) clearance for the THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PL.... 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., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on December 7, 2010 after a review of 117 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., Dba Stryker Orthopaedics devices

Submission Details

510(k) Number K102282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2010
Decision Date December 07, 2010
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
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 907
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K102282.
CONTOURS LAPIDUS PLATING SYSTEM
K102201 · Orthofix, Inc. · Dec 2010
APTUS 1.5 TRILOCK
K102537 · Medartis AG · Dec 2010
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
K102694 · Synthes (Usa) · Dec 2010
EVOLVE EPS ORTHOLOC
K102352 · Wrightmedicaltechnologyinc · Dec 2010
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
K102429 · Wrightmedicaltechnologyinc · Nov 2010
CLAVICLE LOCKING PLATE SYSTEM
K100944 · Newclip Technics · Oct 2010