Cleared Traditional

B-BOP PLATE (K052152) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052152 · New Deal, S.A. · Orthopedic device
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Sep 2005
Decision
36d
Days
Class 2
Risk

K052152 is an FDA 510(k) clearance for the B-BOP PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by New Deal, S.A. (Planisboro, US). The FDA issued a Cleared decision on September 13, 2005 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. 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 New Deal, S.A. devices

Submission Details

510(k) Number K052152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2005
Decision Date September 13, 2005
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K052152.
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K052390 · Synthes (Usa) · Oct 2005
LOW PROFILE PLATE AND SCREW SYSTEM
K052614 · Arthrex, Inc. · Sep 2005
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
K051986 · Synthes (Usa) · Sep 2005
CHARLOTTE COMPRESSION PLATE
K051908 · Wrightmedicaltechnologyinc · Aug 2005
CHARLOTTE SMALL MTP FUSION PLATE
K051884 · Wrightmedicaltechnologyinc · Aug 2005