Cleared Traditional

ELEOS Limb Salvage System with BioGrip (K203815) - FDA 510(k) Clearance

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

K203815 · Onkos Surgical · Orthopedic device
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Jun 2021
Decision
162d
Days
Class 2
Risk

K203815 is an FDA 510(k) clearance for the ELEOS Limb Salvage System with BioGrip. 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 June 9, 2021 after a review of 162 days - an extended review 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: 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 Onkos Surgical devices

Submission Details

510(k) Number K203815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2020
Decision Date June 09, 2021
Days to Decision 162 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
40d slower than avg
Panel avg: 122d · This submission: 162d
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 K203815.
Exeter® X3® RimFit® Cup
K213701 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Feb 2022
MPO Hip Instruments
K213816 · Microport Orthopedics, Inc. · Jan 2022
VerSys Cemented Revision/Calcar
K210842 · Zimmer, Inc. · Dec 2021
ELEOS™ Limb Salvage System
K203588 · Onkos Surgical · Feb 2021
ELEOS Limb Salvage System featuring BIOGRIP
K203090 · Onkos Surgical · Dec 2020
PROFEMUR® GLADIATOR® Cemented Classic Stem
K201519 · Microport Orthopedics, Inc. · Dec 2020