Cleared Traditional

K261511 - Xpert Ankle

K261511 is an FDA 510(k) clearance for Xpert Ankle, manufactured by Newclip Technics. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K261511 · Newclip Technics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
82d
Days
Class 2
Risk

K261511 is an FDA 510(k) clearance for the Xpert Ankle. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on July 28, 2026 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Newclip Technics devices

FDA 510(k) Submission Details - K261511

510(k) Number K261511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2026
Decision Date July 28, 2026
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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

The OrthoMedix Group, Inc.
J.D. Webb

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 1214
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K261511.
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
Versalock Proximal Tibial Plating System
K261406 · GM Dos Reis Industria e Comercio Ltda. · Jul 2026
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD)
K262032 · TriMed, Inc. · Jul 2026
Alians Elbow S
K261191 · Newclip Technics · Jul 2026