Cleared Traditional

K260403 - 7D Surgical System (10-0001)

K260403 is an FDA 510(k) clearance for 7D Surgical System (10-0001), manufactured by 7D Surgical ULC. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K260403 · 7D Surgical ULC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
255d
Days
Class 2
Risk

K260403 is an FDA 510(k) clearance for the 7D Surgical System (10-0001). Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by 7D Surgical ULC (Toronto, CA). The FDA issued a Cleared decision on October 19, 2026 after a review of 255 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 - K260403

510(k) Number K260403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2026
Decision Date October 19, 2026
Days to Decision 255 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
133d slower than avg
Panel avg: 122d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 444
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K260403.
GPS Ankle
K262567 · Blue Ortho · Oct 2026
TMINI Miniature Robotic System
K263234 · THINK Surgical, Inc. · Oct 2026
CarboClear® Cervical Navigated Instruments
K263154 · CarboFix Orhtopedics , Ltd. · Oct 2026
Spine Planning (3.0)
K262257 · Brainlab SE · Sep 2026
Remex Spine Surgery Navigation - Universal Instruments
K262506 · Remex Medical Corp. · Aug 2026
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
K261410 · Suite 201, National Innovation Centre · Jul 2026
K260403 · 7D Surgical System (10-0001)
Download PDF FDA Summary 7D Surgical ULC