Cleared Traditional

K172021 - LigaPASS

K172021 is an FDA 510(k) clearance for LigaPASS, manufactured by Medicrea International SA. The device is a Class 2 Orthopedic device with product code OWI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K172021 · Medicrea International SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
56d
Days
Class 2
Risk

K172021 is an FDA 510(k) clearance for the LigaPASS. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Medicrea International SA (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on August 30, 2017 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medicrea International SA devices

FDA 510(k) Submission Details - K172021

510(k) Number K172021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2017
Decision Date August 30, 2017
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 K172021.
LigaPASS
K173506 · Medicrea International SA · Apr 2018
NuVasive® VersaTie™ System
K173117 · Nuvasive, Inc. · Dec 2017
SILC® Fixation System
K172417 · Globus Medical, Inc. · Oct 2017
TRANSLACE™ Spinal Tethering System
K163181 · Medtronic Sofamor Danek USA, Inc. · May 2017
NILE Proximal Fixation Spinal System
K161332 · K2m, Inc. · Apr 2017
LigaPASS
K160698 · Medicrea International SA · Sep 2016