Cleared Traditional

K220765 - HS Fiber Cerclage (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220765 · Riverpoint Medical, LLC · Orthopedic device
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Jul 2023
Decision
497d
Days
Class 2
Risk

K220765 is an FDA 510(k) clearance for the HS Fiber Cerclage. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Riverpoint Medical, LLC (Portland, US). The FDA issued a Cleared decision on July 26, 2023 after a review of 497 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Riverpoint Medical, LLC devices

Submission Details

510(k) Number K220765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2022
Decision Date July 26, 2023
Days to Decision 497 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
375d slower than avg
Panel avg: 122d · This submission: 497d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 128
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K220765.
Stitch Cerclage – Suture Tapes
K243905 · GM Dos Reis Industria e Comercio Ltda. · Aug 2025
Arthrex FiberTape and TigerTape Cerclage Sutures
K243344 · Arthrex, Inc. · Feb 2025
Mbrace Cable
K232733 · Medacta International S.A. · May 2024
ACCORD Cable System
K233949 · Smith & Nephew, Inc. · Mar 2024
VariTrax Sternal CircumFixation System
K232986 · Circumfix Solutions, Inc. · Jan 2024
Arthrex Radiopaque FiberTape Cerclage sutures
K230976 · Arthrex, Inc. · Aug 2023