Cleared Traditional

K231078 - All-Suture Anchor

K231078 is the FDA 510(k) clearance for All-Suture Anchor by Riverpoint Medical, LLC. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K231078 · Riverpoint Medical, LLC · Orthopedic device
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Oct 2023
Decision
171d
Days
Class 2
Risk

K231078 is an FDA 510(k) clearance for the All-Suture 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 October 5, 2023 after a review of 171 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 Riverpoint Medical, LLC devices

Submission Details

510(k) Number K231078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2023
Decision Date October 05, 2023
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
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 K231078.
Shadow Knotless All-Suture Anchors
K233258 · Responsive Arthroscopy, LLC · Oct 2023
JuggerKnot Soft Anchor OC
K232411 · Riverpoint Medical, LLC · Oct 2023
2.7 mm GRYPHON™ Flex Knotless PEEK Anchor
K232492 · Medos International SARL · Oct 2023
CITRELOCK® DUO
K232592 · Acuitive Technologies, Inc. · Sep 2023
Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)
K230517 · Jarmon Medical, LLC (Dba Legends Orthopedics) · Sep 2023
Q-FIX ULTRA All-Suture Anchor
K232457 · Smith & Nephew · Sep 2023