Cleared Traditional

K053180 - PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS

K053180 is an FDA 510(k) clearance for PARALLAX ACRYLIC RESIN CARTRIDGE WITH T..., manufactured by Arthrocare Corp.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K053180 · Arthrocare Corp. · Orthopedic device
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Jan 2006
Decision
72d
Days
Class 2
Risk

K053180 is an FDA 510(k) clearance for the PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on January 25, 2006 after a review of 72 days - a notably fast clearance cycle.

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: 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 Arthrocare Corp. devices

FDA 510(k) Submission Details - K053180

510(k) Number K053180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date January 25, 2006
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDN Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K053180.
CONFIDENCE HIGH VISCOSITY BONE CEMENT
K060300 · Disc-O-Tech Medical Technologies, Ltd. · Jun 2006
SPINE-FIX BIOMIMETIC BONE CEMENT
K043593 · Teknimed, S.A. · Mar 2006
EBI VERTEBROPLASTY SYSTEMS
K060148 · Ebi, L.P. · Mar 2006
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · Cook, Inc. · Nov 2005
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K043406 · Depuy Spine, Inc. · Jul 2005
PARALLAX ACRYLIC RESIN WITH TRACERS TA
K050864 · Arthrocare Corp. · Jun 2005