Cleared Traditional

K210402 - Curiteva Sacroiliac Joint Fusion System

K210402 is an FDA 510(k) clearance for Curiteva Sacroiliac Joint Fusion System, manufactured by Curiteva, Inc.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K210402 · Curiteva, Inc. · Orthopedic device
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Sep 2021
Decision
211d
Days
Class 2
Risk

K210402 is an FDA 510(k) clearance for the Curiteva Sacroiliac Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on September 9, 2021 after a review of 211 days - an extended review cycle.

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. 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 Curiteva, Inc. devices

FDA 510(k) Submission Details - K210402

510(k) Number K210402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2021
Decision Date September 09, 2021
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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 K210402.
TRELLIS™ SI Joint Fusion System
K212962 · Orthofundamentals, LLC · Apr 2022
Blue Topaz Sacroiliac Screw System
K213590 · Osseus Fusion Systems, LLC · Mar 2022
SIMPACT Sacroiliac Joint Fixation System
K212903 · Life Spine, Inc. · Dec 2021
Triton™ Sacroiliac Joint Fixation System
K211449 · Choice Spine, LLC · Aug 2021
FIREBIRD SI Fusion System
K210667 · Orthofix, Inc. · Mar 2021
Harvester SI: Sacroiliac Fixation System
K203780 · Spinus International, Inc. · Mar 2021