Cleared Special

K020677 - GAMMA 3 LAG SCREW

K020677 is an FDA 510(k) clearance for GAMMA 3 LAG SCREW, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 28-day FDA review.

K020677 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
28d
Days
Class 2
Risk

K020677 is an FDA 510(k) clearance for the GAMMA 3 LAG SCREW. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on March 29, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020677

510(k) Number K020677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date March 29, 2002
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 530
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K020677.
S2 FEMORAL NAIL
K021026 · Howmedica Osteonics Corp. · Apr 2002
S2 TIBIAL NAIL
K021027 · Howmedica Osteonics Corp. · Apr 2002
LONG LENGTH GAMMA NAIL
K020773 · Howmedica Osteonics Corp. · Apr 2002
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER
K013923 · Biomet Orthopedics, Inc. · Feb 2002
T2 FEMORAL NAIL SYSTEM
K014220 · Howmedica Osteonics Corp. · Jan 2002
LONG TROCHANTERIC NAIL SYSTEM
K013563 · DePuy Orthopaedics, Inc. · Dec 2001
K020677 · GAMMA 3 LAG SCREW
Download PDF FDA Summary Howmedica Osteonics C…