Cleared Traditional

K053336 - STAXX FX SYSTEM

K053336 is an FDA 510(k) clearance for STAXX FX SYSTEM, manufactured by Spine Wave, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K053336 · Spine Wave, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
214d
Days
Class 2
Risk

K053336 is an FDA 510(k) clearance for the STAXX FX SYSTEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on July 3, 2006 after a review of 214 days - an extended review 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: 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 Spine Wave, Inc. devices

FDA 510(k) Submission Details - K053336

510(k) Number K053336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2005
Decision Date July 03, 2006
Days to Decision 214 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
92d slower than avg
Panel avg: 122d · This submission: 214d
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 103
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K053336.
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
K062424 · Disc-O-Tech Medical Technologies, Ltd. · Sep 2006
SPACE CPSXL BONE CEMENT
K061531 · Dfine, Inc. · Aug 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
K060425 · Arthrocare Corp. · Jul 2006
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