Cleared Special

K261611 - TDM Large Bone Plate and Screw System

K261611 is an FDA 510(k) clearance for TDM Large Bone Plate and Screw System, manufactured by Tdm Co., Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 140-day FDA review.

K261611 · Tdm Co., Ltd. · Orthopedic device
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Oct 2026
Decision
140d
Days
Class 2
Risk

K261611 is an FDA 510(k) clearance for the TDM Large Bone Plate and Screw System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Tdm Co., Ltd. (Gwangju, KR). The FDA issued a Cleared decision on October 2, 2026 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tdm Co., Ltd. devices

FDA 510(k) Submission Details - K261611

510(k) Number K261611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2026
Decision Date October 02, 2026
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1303
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K261611.
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