Cleared Traditional

K212962 - TRELLIS SI Joint Fusion System

K212962 is an FDA 510(k) clearance for TRELLIS SI Joint Fusion System, manufactured by Orthofundamentals, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K212962 · Orthofundamentals, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Apr 2022
Decision
207d
Days
Class 2
Risk

K212962 is an FDA 510(k) clearance for the TRELLIS™ SI Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Orthofundamentals, LLC (Medford, US). The FDA issued a Cleared decision on April 11, 2022 after a review of 207 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 Orthofundamentals, LLC devices

FDA 510(k) Submission Details - K212962

510(k) Number K212962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2021
Decision Date April 11, 2022
Days to Decision 207 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
85d slower than avg
Panel avg: 122d · This submission: 207d
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 K212962.
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SIMPACT Sacroiliac Joint Fixation System
K212903 · Life Spine, Inc. · Dec 2021
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K210402 · Curiteva, Inc. · Sep 2021