Cleared Traditional

K242494 - OsseoFit Interfacing Anchor

Also marketed or referenced as:
OsseoFit Bone Tunnel Construct

K242494 is the FDA 510(k) clearance for OsseoFit Interfacing Anchor by Riverpoint Medical, LLC. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K242494 · Riverpoint Medical, LLC · Orthopedic device
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Nov 2024
Decision
96d
Days
Class 2
Risk

K242494 is an FDA 510(k) clearance for the OsseoFit Interfacing Anchor. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Riverpoint Medical, LLC (Portland, US). The FDA issued a Cleared decision on November 26, 2024 after a review of 96 days - within the typical 510(k) review window.

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 Riverpoint Medical, LLC devices

Submission Details

510(k) Number K242494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2024
Decision Date November 26, 2024
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 412
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K242494.
OTS 25-L (100-5)
K241234 · Ots Medical , Ltd. · Jan 2025
Tigon Medical All-Suture Anchors (ASA)
K242529 · Tigon Medical · Dec 2024
Fix2Lock (PEEK Self Punching)
K243470 · Osteonic Co., Ltd. · Dec 2024
Iconix Knotless Anchor
K243323 · Riverpoint Medical · Nov 2024
OC JuggerKnotless Soft Anchor
K243203 · Riverpoint Medical · Oct 2024
Extremity All Suture System
K241695 · Field Orthopaedics · Sep 2024