Cleared Traditional

K230817 - TORPEDO Implant System

K230817 is an FDA 510(k) clearance for TORPEDO Implant System, manufactured by Deltacor GmbH. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K230817 · Deltacor GmbH · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K230817

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.

OUR Device Classification - Class 2, Special Controls

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 119
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K230817.
Camber Sacroiliac (SI) Fixation System
K233972 · Camber Spine Technologies · Feb 2024
PathLoc SI Joint Fusion System
K240201 · L & K Biomed Co., Ltd. · Feb 2024
iFuse Bedrock Granite® Implant System
K233508 · SI-BONE, Inc. · Jan 2024
Liberty SI Lateral Implant System
K231923 · Spinal Simplicity, LLC · Dec 2023
SOLACE Sacroiliac Fixation System
K233241 · Ht Medical, LLC Dba Xenix Medical · Oct 2023
REUNION Sacroiliac Joint Fusion System
K232211 · Astura Medical · Oct 2023