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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 1059
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K080649.
APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
K083612 · Cayenne Medical, Inc. · Mar 2009
BIODRIVE CANNULATED SCREW SYSTEM
K082874 · Biomet Trauma · Feb 2009
MAXTORQUE MINI CANNULATED SCREW SYSTEM
K082574 · Orthohelix Surgical Designs, Inc. · Dec 2008
ORTHOPEDIATRICS BONE SCREWS
K082949 · OrthoPediatrics Corp. · Nov 2008
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45
K081011 · Arex USA · Nov 2008
HEALIX TI ANCHOR
K082282 · Depuy Mitek, A Johnson & Johnson Co. · Nov 2008
K080649 · POGO SCREW
Download PDF FDA Summary Fxdevices