Cleared Traditional

K081588 - RE-ZORB PLATING SYSTEM

K081588 is an FDA 510(k) clearance for RE-ZORB PLATING SYSTEM, manufactured by Acute Innovations, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K081588 · Acute Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
90d
Days
Class 2
Risk

K081588 is an FDA 510(k) clearance for the RE-ZORB 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 Acute Innovations, LLC (Hillsboro, US). The FDA issued a Cleared decision on September 3, 2008 after a review of 90 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 Acute Innovations, LLC devices

FDA 510(k) Submission Details - K081588

510(k) Number K081588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2008
Decision Date September 03, 2008
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1054
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K081588.
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
K081374 · Wrightmedicaltechnologyinc · Sep 2008
SYNTHES RIB FIXATION SYSTEM
K081623 · Synthes (Usa) · Sep 2008
AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K080992 · Aesculap Implant Systems, Inc. · Sep 2008
SMALL BONE LOCKING PLATING SYSTEM
K081546 · DePuy Orthopaedics, Inc. · Aug 2008
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
K081353 · Synthes (Usa) · Jul 2008
ORTHOPEDIATRICS PEDIPLATES SYSTEM
K081407 · OrthoPediatrics Corp. · Jul 2008