Cleared Traditional

K080649 - POGO SCREW

K080649 is an FDA 510(k) clearance for POGO SCREW, manufactured by Fxdevices. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K080649 · Fxdevices · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2008
Decision
263d
Days
Class 2
Risk

K080649 is an FDA 510(k) clearance for the POGO SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Fxdevices (Boca Raton, US). The FDA issued a Cleared decision on November 25, 2008 after a review of 263 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K080649

510(k) Number K080649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2008
Decision Date November 25, 2008
Days to Decision 263 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
141d slower than avg
Panel avg: 122d · This submission: 263d
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 776
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K080649.
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
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K083612 · Cayenne Medical, Inc. · Mar 2009
MAXTORQUE MINI CANNULATED SCREW SYSTEM
K082574 · Orthohelix Surgical Designs, Inc. · Dec 2008
ORTHOPEDIATRICS BONE SCREWS
K082949 · OrthoPediatrics Corp. · Nov 2008
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K082320 · Wrightmedicaltechnologyinc · Nov 2008
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
K081893 · Arthrocare Corp. · Oct 2008