Cleared Traditional

K230817 - TORPEDO Implant System® (FDA 510(k) Clearance)

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

K230817 · Deltacor GmbH · Orthopedic device
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Jan 2024
Decision
301d
Days
Class 2
Risk

K230817 is an FDA 510(k) clearance for the TORPEDO Implant System®. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Deltacor GmbH (Werneck, DE). The FDA issued a Cleared decision on January 19, 2024 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Elevated predicate reliance profile. 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 Deltacor GmbH devices

Submission Details

510(k) Number K230817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2023
Decision Date January 19, 2024
Days to Decision 301 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 122d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
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 - OUR Sacroiliac Joint Fixation

All 130
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K230817.
CATAMARAN™ SI Joint Fusion System
K260477 · Tenon Medical · Apr 2026
iFuse INTRA Ti™ Implant System
K253488 · SI-BONE, Inc. · Feb 2026
Falco Fusion System
K253611 · Mcnicoll Surgical, Inc. · Jan 2026
Sacroiliac Joint Truss System (SJTS)
K252834 · 4Web Medical · Jan 2026
OptumSI Implant System
K251365 · Si Solutions, LLC · Nov 2025
SIros-X System
K252322 · Genesys Spine · Oct 2025