Cleared Traditional

K111265 - METASURG SUBTALAR IMPLANT

K111265 is an FDA 510(k) clearance for METASURG SUBTALAR IMPLANT, manufactured by Metasurg. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K111265 · Metasurg · Orthopedic device
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Aug 2011
Decision
97d
Days
Class 2
Risk

K111265 is an FDA 510(k) clearance for the METASURG SUBTALAR IMPLANT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Metasurg (Houston, US). The FDA issued a Cleared decision on August 9, 2011 after a review of 97 days - within the typical 510(k) review window.

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.

View all Metasurg devices

FDA 510(k) Submission Details - K111265

510(k) Number K111265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2011
Decision Date August 09, 2011
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 756
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K111265.
ZIMMER PERIARTICULAR SCREWS
K111447 · Zimmer, Inc. · Oct 2011
MICROSUTURE ANCHORS
K112237 · Arthrex, Inc. · Sep 2011
SLIC SCREW REPAIR SYSTEM
K111608 · Acumed, LLC · Aug 2011
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
K111000 · Parcus Medical, LLC · Jul 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · Synthes (Usa) · Jul 2011
AAP CANNULATED SCREWS
K111316 · Aap Implantate AG · Jul 2011