Cleared Traditional

K261647 - Tempo Plating System

Also marketed or referenced as:
Ultra Compression Screw System

K261647 is an FDA 510(k) clearance for Tempo Plating System, manufactured by Pace Surgical. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K261647 · Pace Surgical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
107d
Days
Class 2
Risk

K261647 is an FDA 510(k) clearance for the Tempo 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 Pace Surgical (Malvern, US). The FDA issued a Cleared decision on September 3, 2026 after a review of 107 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. 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 Pace Surgical devices

FDA 510(k) Submission Details - K261647

510(k) Number K261647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2026
Decision Date September 03, 2026
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 Consultant

MRC Global, LLC
Danielle Besal

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K261647.
ProRib Fixation System
K261892 · Costa Surgical, Inc. · Sep 2026
EnHAnce PEEK Bunion System
K262098 · Nvision Biomedical Technologies · Sep 2026
TMC Implant Fixation System
K262963 · Treace Medical Concepts, Inc. · Sep 2026
FRAXION 3.5 Plate System (Various - See Catalog)
K261830 · Ortler Global Tibbi Gerecler Anonim Sirketi · Aug 2026
Versalock Sterile Plating System
K262537 · GM Dos Reis Industria e Comercio Ltda. · Aug 2026
MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
K260277 · Mikron Makina San. ve Tic. Ltd. Sti. · Aug 2026