Cleared Traditional

K160304 - OsteoBullet Compression Screw

K160304 is an FDA 510(k) clearance for OsteoBullet Compression Screw, manufactured by Phalanx Innovations. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K160304 · Phalanx Innovations · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
85d
Days
Class 2
Risk

K160304 is an FDA 510(k) clearance for the OsteoBullet Compression Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Phalanx Innovations (Marietta, US). The FDA issued a Cleared decision on April 29, 2016 after a review of 85 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 Phalanx Innovations devices

FDA 510(k) Submission Details - K160304

510(k) Number K160304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2016
Decision Date April 29, 2016
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 736
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K160304.
Arthrosurface Bone Screws
K161539 · Arthrosurface, Inc. · Jun 2016
The Life Spine Subtalar Implant System
K160169 · Life Spine · Jun 2016
Large Screws Range
K160617 · Newclip Technics · Jun 2016
MC-Subtalar(TM) II
K160548 · Merete Medical GmbH · Apr 2016
Biomet Variable Pitch Compression Screw System
K160058 · Biomet, Inc. · Mar 2016
Tyber Medical Trauma Screw
K153575 · Tyber Medical, LLC · Feb 2016