Cleared Traditional

ELEOS™ Limb Salvage System (K203588) - FDA 510(k) Clearance

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

K203588 · Onkos Surgical · Orthopedic device
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Feb 2021
Decision
59d
Days
Class 2
Risk

K203588 is an FDA 510(k) clearance for the ELEOS™ Limb Salvage System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Onkos Surgical (Parsippany, US). The FDA issued a Cleared decision on February 5, 2021 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Onkos Surgical devices

Submission Details

510(k) Number K203588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2020
Decision Date February 05, 2021
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 281
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K203588.
MPO Hip Instruments
K213816 · Microport Orthopedics, Inc. · Jan 2022
VerSys Cemented Revision/Calcar
K210842 · Zimmer, Inc. · Dec 2021
ELEOS Limb Salvage System with BioGrip
K203815 · Onkos Surgical · Jun 2021
ELEOS Limb Salvage System featuring BIOGRIP
K203090 · Onkos Surgical · Dec 2020
PROFEMUR® GLADIATOR® Cemented Classic Stem
K201519 · Microport Orthopedics, Inc. · Dec 2020
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
K193429 · Howmedica Osteonics Corp. · Aug 2020