Cleared Traditional

K222097 - OLYMPIC Deformity Band System

K222097 is an FDA 510(k) clearance for OLYMPIC Deformity Band System, manufactured by Astura Medical. The device is a Class 2 Orthopedic device with product code OWI cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K222097 · Astura Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
290d
Days
Class 2
Risk

K222097 is an FDA 510(k) clearance for the OLYMPIC Deformity Band System. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Astura Medical (Irving, US). The FDA issued a Cleared decision on May 4, 2023 after a review of 290 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 Astura Medical devices

FDA 510(k) Submission Details - K222097

510(k) Number K222097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2022
Decision Date May 04, 2023
Days to Decision 290 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
168d slower than avg
Panel avg: 122d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWI Device Classification - Class 2, Special Controls

Product Code OWI Bone Fixation Cerclage, Sublaminar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
Definition Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal 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 - OWI Bone Fixation Cerclage, Sublaminar

All 36
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K222097.
LigaPASS™ System
K261374 · Medicrea International S.A.S · May 2026
Invictus Bands System
K253615 · Alphatec Spine, Inc. · Mar 2026
HILINE™ Fixation System
K230565 · Globus Medical, Inc. · Apr 2023
LigaPASS™ 2.0 Ligament Augmentation System
K213659 · Medicrea International SA · May 2022
LigaPASS® Spinal System, CD Horizon™ Spinal System
K211057 · Medtronic, Inc. · May 2021
Mariner Cap System
K201240 · SeaSpine Orthopedics Corporation · Aug 2020