Data / Medical devices / United States / Onkos Surgical, Inc.

Onkos Surgical, Inc.: FDA-registered device maker in Parsippany, NJ, United States, 10 510(k) clearances

Name: Onkos Surgical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Onkos Surgical, Inc. is registered with the FDA (registration 3013450937) in Parsippany, NJ, United States. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 15, 2025. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013450937
Address: 77 E Halsey RD, Parsippany, NJ, United States, 07054
Owner or operator: Onkos Surgical (10054049)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: February 6, 2017
Registered through: 2026
Brand names listed: ELEOS, ELEOS Limb Salvage System, ELEOS Limb Salvage System with BioGrip, ELEOS Limb Salvage System with NanoCept® Technology, JTS Extendible Implant and associated instrumentation, JTS Extendible Implant and related instrumentation, My3D Personalized Pelvic Reconstruction, NanoCept®

Devices it lists

Device	Product code	Class	Role	Source
Limb And Joint Salvage Device With Coating For Bacteria Reduction	QZZ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	KRO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Template	HWT	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 15, 2025	K252920	ELEOS Limb Salvage System with NanoCept® Technology	QZZ	Substantially Equivalent	Onkos Surgical, Inc.	accessdata.fda.gov
April 5, 2024	DEN210058	ELEOSx Limb Salvage System	QZZ	Unknown	Onkos Surgical	accessdata.fda.gov
January 30, 2023	K223348	My3D® Personalized Pelvic Reconstruction	LPH	Substantially Equivalent	Onkos Surgical, Inc.	accessdata.fda.gov
July 6, 2022	K212815	My3D® Personalized Pelvic Reconstruction	LPH	Substantially Equivalent	Onkos Surgical	accessdata.fda.gov
June 9, 2021	K203815	ELEOS Limb Salvage System with BioGrip	JDI	Substantially Equivalent	Onkos Surgical	accessdata.fda.gov
February 5, 2021	K203588	ELEOS Limb Salvage System	JDI	Substantially Equivalent	Onkos Surgical	accessdata.fda.gov
December 11, 2020	K203090	ELEOS Limb Salvage System featuring BIOGRIP	JDI	Substantially Equivalent	Onkos Surgical	accessdata.fda.gov
October 28, 2016	K161520	ELEOS Limb Salvage System	KRO	Substantially Equivalent	Onkos Surgical, Inc.	accessdata.fda.gov
January 22, 2014	K133152	JTS EXTENDIBLE DISTAL FEMORAL IMPLANT	KRO	Substantially Equivalent	Stanmore Implants Worldwide , Ltd.	accessdata.fda.gov
March 22, 2011	K092138	JTS EXTENDEABLE IMPLANT	KRO	Substantially Equivalent	Stanmore Implants Worldwide , Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 24, 2026	99692	Class II	Ongoing	Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M	Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.	accessdata.fda.gov
July 11, 2025	97343	Class II	Ongoing	ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.	Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.	accessdata.fda.gov
May 20, 2025	97005	Class II	Ongoing	My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device	Required inspections were not performed on finished product prior to release and distribution.	accessdata.fda.gov
September 22, 2024	96780	Class II	Ongoing	ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System	Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.	accessdata.fda.gov
December 22, 2023	96781	Class II	Ongoing	ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.	Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.	accessdata.fda.gov
September 1, 2023	96782	Class II	Ongoing	a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M	Potential for breach of Tyvek seals.	accessdata.fda.gov
May 23, 2017	77309	Class II	Terminated	ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E	The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm	accessdata.fda.gov

Compare with other makers

Updated October 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.