Cleared Traditional

K253615 - Invictus Bands System

K253615 is an FDA 510(k) clearance for Invictus Bands System, manufactured by Alphatec Spine, Inc.. The device is a Class 2 Orthopedic device with product code OWI cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K253615 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
127d
Days
Class 2
Risk

K253615 is an FDA 510(k) clearance for the Invictus Bands System. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 25, 2026 after a review of 127 days - within the typical 510(k) review window.

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 Alphatec Spine, Inc. devices

FDA 510(k) Submission Details - K253615

510(k) Number K253615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2025
Decision Date March 25, 2026
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 27
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K253615.
LigaPASS™ System
K261374 · Medicrea International S.A.S · May 2026
OLYMPIC Deformity Band System
K222097 · Astura Medical · May 2023
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