Cleared Traditional

K221621 - Pro-X1™ Trochanteric Nailing System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221621 · X-Bolt Orthopedics · Orthopedic device
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Mar 2023
Decision
276d
Days
Class 2
Risk

K221621 is an FDA 510(k) clearance for the Pro-X1™ Trochanteric Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by X-Bolt Orthopedics (Santry, IE). The FDA issued a Cleared decision on March 6, 2023 after a review of 276 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 X-Bolt Orthopedics devices

Submission Details

510(k) Number K221621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2022
Decision Date March 06, 2023
Days to Decision 276 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
154d slower than avg
Panel avg: 122d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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

Mcra, LLC
Hollace Saas Rhodes

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 - HSB Rod, Fixation, Intramedullary And Accessories

All 522
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K221621.
AUTOBAHN™ Nailing System
K261043 · Globus Medical, Inc. · Apr 2026
Arthrex Humeral Nails
K252016 · Arthrex, Inc. · Mar 2026
Fusion FibFix Nail
K252961 · Fusion Orthopedics USA, LLC · Mar 2026
Affixus Retrograde Femoral Nailing System
K253566 · Zimmer, Inc. · Mar 2026
Reselute Tibial Nail
K253517 · Reselute, Inc. · Mar 2026
Arthrex FibuLock Nail System
K252196 · Arthrex, Inc. · Mar 2026