Cleared Traditional

K051083 - ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM

K051083 is an FDA 510(k) clearance for ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM, manufactured by Acumed, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K051083 · Acumed, LLC · Orthopedic device
Download Printable Device Report (PDF)
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May 2005
Decision
15d
Days
Class 2
Risk

K051083 is an FDA 510(k) clearance for the ACUMED SCAPULA CONGRUENT BONE PLATE 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 Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on May 12, 2005 after a review of 15 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acumed, LLC devices

FDA 510(k) Submission Details - K051083

510(k) Number K051083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2005
Decision Date May 12, 2005
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
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 946
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K051083.
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
K050681 · TriMed, Inc. · Jul 2005
ACUMED RIB CONGRIENT BONE PLATE SYSTEM
K051410 · Acumed, LLC · Jul 2005
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
K051735 · Smith & Nephew, Inc. · Jul 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646 · Synthes (Usa) · Apr 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607 · Synthes (Usa) · Apr 2005
STRYKER LOCKED PLATING SYSTEM
K050512 · Howmedica Osteonics Corp. · Mar 2005