Cleared Traditional

K060300 - CONFIDENCE HIGH VISCOSITY BONE CEMENT

K060300 is an FDA 510(k) clearance for CONFIDENCE HIGH VISCOSITY BONE CEMENT, manufactured by Disc-O-Tech Medical Technologies, Ltd.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K060300 · Disc-O-Tech Medical Technologies, Ltd. · Orthopedic device
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Jun 2006
Decision
135d
Days
Class 2
Risk

K060300 is an FDA 510(k) clearance for the CONFIDENCE HIGH VISCOSITY BONE CEMENT. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Disc-O-Tech Medical Technologies, Ltd. (Herzliya, IL). The FDA issued a Cleared decision on June 21, 2006 after a review of 135 days - within the typical 510(k) review window.

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. 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 Disc-O-Tech Medical Technologies, Ltd. devices

FDA 510(k) Submission Details - K060300

510(k) Number K060300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2006
Decision Date June 21, 2006
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
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 56
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K060300.
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
K062424 · Disc-O-Tech Medical Technologies, Ltd. · Sep 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
K060425 · Arthrocare Corp. · Jul 2006
STAXX FX SYSTEM
K053336 · Spine Wave, Inc. · Jul 2006
EBI VERTEBROPLASTY SYSTEMS
K060148 · Ebi, L.P. · Mar 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
K053180 · Arthrocare Corp. · Jan 2006
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · Cook, Inc. · Nov 2005