Cleared Traditional

K222097 - OLYMPIC Deformity Band System (FDA 510(k) Clearance)

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

K222097 · Astura Medical · Orthopedic device
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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

Submission Details

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.

Device Classification

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 35
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K222097.
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