Atlas FDA

ELEOS Limb Salvage System

FDA 510(k) clearance K161520 · decided 2016-10-28

Clearance details

K-number
K161520
Device name
ELEOS Limb Salvage System
Applicant
Onkos Surgical, Inc.
Decision
Substantially Equivalent
Date received
2016-06-02
Decision date
2016-10-28
Days to decision
148 days
Clearance type
Traditional
Product code
KRO
Device class
2
Regulation number
888.3510
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Parsippany, NJ, US
Third-party review
No
Expedited review
No

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ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980)Depuy Ireland UC2024-03-21
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Recalls involving this device

RecordFirmDate
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem i recall (Z-2423-2025)Onkos Surgical, Inc.2025-08-25
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED S recall (Z-2424-2025)Onkos Surgical, Inc.2025-08-25
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Can recall (Z-2425-2025)Onkos Surgical, Inc.2025-08-25
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-1010 recall (Z-1879-2025)Onkos Surgical, Inc.2025-05-29
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12 recall (Z-1881-2025)Onkos Surgical, Inc.2025-05-29
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152- recall (Z-1882-2025)Onkos Surgical, Inc.2025-05-29
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsecti recall (Z-1884-2025)Onkos Surgical, Inc.2025-05-29
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage recall (Z-1857-2025)Onkos Surgical, Inc.2025-05-28