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ONKOS SURGICAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 77 E HALSEY RD, Parsippany, NJ, 07054
Website: onkossurgical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(844)767-2766
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3013450937
DUNS Number: 080254074

Catalogue (800)

Page 4 of 16

Device	Model / Reference	Registries	Class	Status
Jts Extendible Distal Femoral Implant	mktp/Sm5	FDA UDI	Class II	Active
Eleos™	K0050521E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	DV-RGDMD-04N	FDA UDI	Class II	Active
Eleos™	K0053018E	FDA UDI	Class I	Active
Eleos™	K0053017E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50095-04M	FDA UDI	Class II	Active
Eleos™	25107105E	FDA UDI	Class I	Active
Eleos™	001-03-10006	FDA UDI	Class I	Active
Eleos™	25100003E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	AM-C3DMD-04N	FDA UDI	Class II	Active
ELEOS™ Limb Salvage System	001-03-00022	FDA UDI	Class I	Active
ELEOS Limb Salvage System	FB-12152-03M	FDA UDI	Class II	Active
Eleos™	25107802E	FDA UDI	Class I	Active
Eleos™	RT-15000-03N	FDA UDI	Class I	Active
Eleos™	KTAGB105E	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	PB-2400R-03M	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	imtibjig/prg	FDA UDI	Class II	Active
Eleos™	25107613E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50055-04M	FDA UDI	Class II	Active
Eleos™	K0053044E	FDA UDI	Class I	Active
Eleos™	001-03-11200	FDA UDI	Class I	Active
Eleos™	26010009E	FDA UDI	Class II	Active
Eleos™	2510L002E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50016-04M	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	DR-43200-04N	FDA UDI	Class II	Active
Eleos™	K0031000E	FDA UDI	Class I	Active
Eleos™	25000111E	FDA UDI	Class II	Active
Eleos™	18056061E	FDA UDI	Class I	Active
Eleos™	K0027101E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	CS-65020-04M	FDA UDI	Class II	Active
ELEOS Limb Salvage System	FS-20120-03M	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	HB-2400R-03M	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	ibnpin	FDA UDI	Class II	Active
Eleos™	25102113E	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	HC-09100-03M	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	LS-50042-04M	FDA UDI	Class II	Active
Eleos™	25001212E	FDA UDI	Class II	Active
ELEOS Limb Salvage System	FS-15120-03M	FDA UDI	Class II	Active
Eleos™	RT-10000-03N	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	tmktp/Std15	FDA UDI	Class II	Active
Eleos™	SPSEB017E	FDA UDI	Class II	Active
Eleos™	K0053015E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	imardrl	FDA UDI	Class II	Active
Eleos™	KTAGB510E	FDA UDI	Class II	Active
Eleos™	K0051420E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	imbc/nut	FDA UDI	Class II	Active
Eleos™	RT-10500-03N	FDA UDI	Class I	Active
Eleos™	RT-14500-03N	FDA UDI	Class I	Active
Eleos™	KPTRTP41E	FDA UDI	Class I	Active
Eleos™	001-03-10003	FDA UDI	Class I	Active

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Authorities

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FDA Recalls (16)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 11, 2025	Z-2424-2025	—	open, classified	Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Jul 11, 2025	Z-2423-2025	—	open, classified	Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Jul 11, 2025	Z-2425-2025	—	open, classified	Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
May 20, 2025	Z-2042-2025	—	open, classified	Required inspections were not performed on finished product prior to release and distribution.
Sep 22, 2024	Z-1857-2025	—	open, classified	Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Dec 22, 2023	Z-1818-2025	—	open, classified	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.
Dec 22, 2023	Z-1817-2025	—	open, classified	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.
Sep 1, 2023	Z-1882-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1880-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1884-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1883-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1881-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1879-2025	—	open, classified	Potential for breach of Tyvek seals.
May 23, 2017	Z-2646-2017	—	terminated	The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
May 23, 2017	Z-2648-2017	—	terminated	The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
May 23, 2017	Z-2647-2017	—	terminated	The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm