Cleared Traditional

K091069 - MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT

K091069 is the FDA 510(k) clearance for MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT by Medacta International S.A.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K091069 · Medacta International S.A. · Orthopedic device
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Jun 2009
Decision
48d
Days
Class 2
Risk

K091069 is an FDA 510(k) clearance for the MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medacta International S.A. (San Diego, US). The FDA issued a Cleared decision on June 1, 2009 after a review of 48 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 Medacta International S.A. devices

Submission Details

510(k) Number K091069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2009
Decision Date June 01, 2009
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 575
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K091069.
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N
K092133 · Arthrocare Corp. · Nov 2009
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949 · Synthes (Usa) · Jul 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · Smith & Nephew, Inc. · Jun 2009
ORTHOPEDIATRICS BONE SCREWS
K082949 · OrthoPediatrics Corp. · Nov 2008
DARCO SMALL SCREW
K082320 · Wrightmedicaltechnologyinc · Nov 2008
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
K081893 · Arthrocare Corp. · Oct 2008