Cleared Traditional

K111834 - DISCO SUBTALAR IMPLANT

K111834 is an FDA 510(k) clearance for DISCO SUBTALAR IMPLANT, manufactured by Trilliant Surgical, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K111834 · Trilliant Surgical, Ltd. · Orthopedic device
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Dec 2011
Decision
160d
Days
Class 2
Risk

K111834 is an FDA 510(k) clearance for the DISCO SUBTALAR IMPLANT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Trilliant Surgical, Ltd. (Round Rock, US). The FDA issued a Cleared decision on December 6, 2011 after a review of 160 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 Trilliant Surgical, Ltd. devices

FDA 510(k) Submission Details - K111834

510(k) Number K111834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2011
Decision Date December 06, 2011
Days to Decision 160 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
38d slower than avg
Panel avg: 122d · This submission: 160d
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 726
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K111834.
COLS PEEK
K113591 · Fournitures Hospitalieres Industrie · Dec 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · Zimmer, Inc. · Dec 2011
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028 · Globus Medical, Inc. · Dec 2011
SYNTHES CORTICAL SCREWS
K112583 · Synthes USA Products, LLC · Dec 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · Smith & Nephew, Inc. · Oct 2011
ORTHOLOC(TM) BONE SCREWS
K112772 · Wrightmedicaltechnologyinc · Oct 2011