Cleared Traditional

K122293 - PIONEER STERNAL CABLE PLATE SYSTEM

K122293 is an FDA 510(k) clearance for PIONEER STERNAL CABLE PLATE SYSTEM, manufactured by Pioneer Surgical Technology, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K122293 · Pioneer Surgical Technology, Inc. · Orthopedic device
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Oct 2012
Decision
73d
Days
Class 2
Risk

K122293 is an FDA 510(k) clearance for the PIONEER STERNAL CABLE 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 Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on October 12, 2012 after a review of 73 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 Pioneer Surgical Technology, Inc. devices

FDA 510(k) Submission Details - K122293

510(k) Number K122293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2012
Decision Date October 12, 2012
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 1254
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K122293.
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
K113601 · Aap Implantate AG · Nov 2012
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
K113602 · Aap Implantate AG · Oct 2012
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
K121651 · Wrightmedicaltechnologyinc · Oct 2012
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122737 · Skeletal Dynamics, LLC · Oct 2012
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
K121425 · Wrightmedicaltechnologyinc · Oct 2012
AFT PROXIMAL HUMERUS FRACTURE PLATE
K121672 · Shoulder Options, Inc. · Oct 2012