Cleared Traditional

K050864 - PARALLAX ACRYLIC RESIN WITH TRACERS TA

K050864 is the FDA 510(k) clearance for PARALLAX ACRYLIC RESIN WITH TRACERS TA by Arthrocare Corp.. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K050864 · Arthrocare Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2005
Decision
73d
Days
Class 2
Risk

K050864 is an FDA 510(k) clearance for the PARALLAX ACRYLIC RESIN WITH TRACERS TA. 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 June 17, 2005 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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

Submission Details

510(k) Number K050864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2005
Decision Date June 17, 2005
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.

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 44
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K050864.
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
K053180 · Arthrocare Corp. · Jan 2006
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · Cook, Inc. · Nov 2005
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K043406 · Depuy Spine, Inc. · Jul 2005
CONCORD Radiopaque Bone Cement
K042168 · Globus Medical, Inc. · Jan 2005
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
K042947 · Arthrocare Corp. · Dec 2004