Cleared Traditional

K111971 - SYNDE-LOCK SYNDESMOSIS REPAIR KIT

K111971 is an FDA 510(k) clearance for SYNDE-LOCK SYNDESMOSIS REPAIR KIT, manufactured by Tarsus Medical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K111971 · Tarsus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
196d
Days
Class 2
Risk

K111971 is an FDA 510(k) clearance for the SYNDE-LOCK SYNDESMOSIS REPAIR KIT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tarsus Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on January 23, 2012 after a review of 196 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.

View all Tarsus Medical, Inc. devices

FDA 510(k) Submission Details - K111971

510(k) Number K111971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2011
Decision Date January 23, 2012
Days to Decision 196 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 slower than avg
Panel avg: 122d · This submission: 196d
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 920
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