Cleared Traditional

K111443 - X12 STERILE REFLECTIVE MARKER SPHERE (FDA 510(k) Clearance)

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

K111443 · Pinsco Inc. Dba B & L Engineering · Orthopedic device
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Sep 2011
Decision
128d
Days
Class 2
Risk

K111443 is an FDA 510(k) clearance for the X12 STERILE REFLECTIVE MARKER SPHERE. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Pinsco Inc. Dba B & L Engineering (Santa Ana, US). The FDA issued a Cleared decision on September 29, 2011 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 Pinsco Inc. Dba B & L Engineering devices

Submission Details

510(k) Number K111443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2011
Decision Date September 29, 2011
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 422
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K111443.
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SPINEART Navigation Instrument System
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SYMPHONY Navigation Ready Instruments
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REAL INTELLIGENCE™ CORI™
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CUVIS-joint (CJ150)
K252037 · Curexo, Inc. · Mar 2026
TiLink-L Navigation Instruments
K253604 · SurGenTec, LLC · Mar 2026