Cleared Special

K161041 - OsteoMed ExtremiLOCK Wrist Plating System

K161041 is an FDA 510(k) clearance for OsteoMed ExtremiLOCK Wrist Plating System, manufactured by Osteomed. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 36-day FDA review.

K161041 · Osteomed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
36d
Days
Class 2
Risk

K161041 is an FDA 510(k) clearance for the OsteoMed ExtremiLOCK Wrist Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on May 19, 2016 after a review of 36 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 Osteomed devices

FDA 510(k) Submission Details - K161041

510(k) Number K161041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2016
Decision Date May 19, 2016
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
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 1308
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K161041.
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
K153374 · Orthocare · Jun 2016
NEOVIEW Plating System
K160995 · In2bones Sas · Jun 2016
AxSOS 3Ti
K153379 · Stryker GmbH · May 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
K153716 · Gpc Medical, Ltd. · May 2016
Gridlock Ankle Plating System
K160177 · Trilliant Surgical, Ltd. · Apr 2016