Cleared Traditional

NEXA BONE SCREW SYSTEM (K053394) - FDA 510(k) Clearance

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

K053394 · Nexa Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
8d
Days
Class 2
Risk

K053394 is an FDA 510(k) clearance for the NEXA BONE SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Nexa Orthopedics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 14, 2005 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Nexa Orthopedics, Inc. devices

Submission Details

510(k) Number K053394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2005
Decision Date December 14, 2005
Days to Decision 8 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
114d faster than avg
Panel avg: 122d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K053394.
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR
K053344 · Smith & Nephew, Inc. · Feb 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
K053338 · Arthrex, Inc. · Jan 2006
5TH METATARSAL FRACTURE SCREW
K053136 · Wrightmedicaltechnologyinc · Jan 2006
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
K052607 · Arthrex, Inc. · Nov 2005
ARTHREX TENODESIS FAMILY
K051726 · Arthrex, Inc. · Sep 2005
PLC SCREW
K051310 · Smith & Nephew, Inc. · Jul 2005