Cleared Traditional

K190289 - Karma Fixation System

K190289 is the FDA 510(k) clearance for Karma Fixation System by Spinal Elements, Inc.. It is a Class 2 Orthopedic device (product code OWI) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K190289 · Spinal Elements, Inc. · Orthopedic device
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Apr 2019
Decision
51d
Days
Class 2
Risk

K190289 is an FDA 510(k) clearance for the Karma® Fixation System. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 3, 2019 after a review of 51 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 Spinal Elements, Inc. devices

Submission Details

510(k) Number K190289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2019
Decision Date April 03, 2019
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 25
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K190289.
The Gecko Spinal System
K200281 · Ortho Development Corporation · Mar 2020
Response BandLoc Spinal Fixation
K200097 · OrthoPediatrics Corp. · Mar 2020
JAZZ PF
K191217 · Implanet, S.A. · Aug 2019
NuVasive® VersaTie® System
K190418 · Nu Vasive, Incorporated · Mar 2019
Spinal Elements Cerclage System
K180728 · Spinal Elements, Inc. · Sep 2018
ResCUBE™ Ligament Fixation System
K181799 · Cousin Biotech Sas · Aug 2018