Cleared Traditional

K122503 - PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON (FDA 510(k) Clearance)

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

K122503 · Neuro Therm, Inc. · Orthopedic device
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Jun 2013
Decision
313d
Days
Class 2
Risk

K122503 is an FDA 510(k) clearance for the PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATAB.... Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Neuro Therm, Inc. (Ashland, US). The FDA issued a Cleared decision on June 25, 2013 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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. Elevated predicate reliance profile. 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 Neuro Therm, Inc. devices

Submission Details

510(k) Number K122503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2012
Decision Date June 25, 2013
Days to Decision 313 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
191d slower than avg
Panel avg: 122d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 107
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