Cleared Traditional

K053394 - NEXA BONE SCREW SYSTEM

K053394 is an FDA 510(k) clearance for NEXA BONE SCREW SYSTEM, manufactured by Nexa Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K053394 · Nexa Orthopedics, Inc. · Orthopedic device
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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

FDA 510(k) Submission Details - K053394

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 763
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K053394.
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
K053338 · Arthrex, Inc. · Jan 2006
NEXA COMPRESSION SCREW
K060071 · Nexa Orthopedics, Inc. · Jan 2006
5TH METATARSAL FRACTURE SCREW
K053136 · Wrightmedicaltechnologyinc · Jan 2006
KALIX II IMPLANT, MODEL 141 0XX WITH XX
K053093 · New Deal, S.A. · Dec 2005
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
K052607 · Arthrex, Inc. · Nov 2005
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052630 · Depuy Mitek, A Johnson & Johnson Company · Oct 2005