Cleared Traditional

K211613 - Stern Fix Sternal Stabilization System (FDA 510(k) Clearance)

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

K211613 · Neos Surgery S.L · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
238d
Days
Class 2
Risk

K211613 is an FDA 510(k) clearance for the Stern Fix Sternal Stabilization System. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Neos Surgery S.L (Barcelona, ES). The FDA issued a Cleared decision on January 19, 2022 after a review of 238 days - an extended review cycle.

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: 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 Neos Surgery S.L devices

Submission Details

510(k) Number K211613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2021
Decision Date January 19, 2022
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
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 Consultant

Msquared Associates, Inc.
Cherita James

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDQ Cerclage, Fixation

All 128
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K211613.
Stitch Cerclage – Suture Tapes
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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