Cleared Traditional

K261135 - Trochlear Salvage Plating System

K261135 is an FDA 510(k) clearance for Trochlear Salvage Plating System, manufactured by Skeletal Dynamics, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K261135 · Skeletal Dynamics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
202d
Days
Class 2
Risk

K261135 is an FDA 510(k) clearance for the Trochlear Salvage Plating 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 Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on October 26, 2026 after a review of 202 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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.

FDA 510(k) Submission Details - K261135

510(k) Number K261135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2026
Decision Date October 26, 2026
Days to Decision 202 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
80d slower than avg
Panel avg: 122d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1331
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K261135.
Arthrex Plates, Screws and Pins, and Washers
K263602 · Arthrex, Inc. · Oct 2026
ANTHEM™ Fracture System
K262779 · Globus Medical, Inc. · Oct 2026
Tempo Plating System
K263407 · Pace Surgical · Oct 2026
Park's Pectus System
K263269 · Tdm Co., Ltd. · Oct 2026
TDM Large Bone Plate and Screw System
K261611 · Tdm Co., Ltd. · Oct 2026
Alians Forearm
K262649 · Newclip Technics · Sep 2026
K261135 · Trochlear Salvage Plating System
Download PDF FDA Summary Skeletal Dynamics, In…