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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 7 of 16

Device	Model / Reference	Registries	Class	Status
Eleos™	25107809E	FDA UDI	Class I	Active
Eleos™	KSC01865E	FDA UDI	Class II	Active
Eleos™	KSC10100E	FDA UDI	Class II	Active
Eleos™	KTAGB215E	FDA UDI	Class II	Active
Eleos™	K0056010E	FDA UDI	Class I	Active
Eleos™	K0051016E	FDA UDI	Class I	Active
Eleos™	25107500E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	DR-43050-04N	FDA UDI	Class II	Active
Eleos™	K0053045E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50045-04M	FDA UDI	Class II	Active
Eleos™	25107207E	FDA UDI	Class I	Active
Eleos™	K0014407E	FDA UDI	Class I	Active
Eleos™	RT-16500-03N	FDA UDI	Class I	Active
Eleos™	KSC16100E	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	LS-50032-04M	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	DV-35000-04N	FDA UDI	Class II	Active
Eleos™	K0050012E	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	PL-00021-03N	FDA UDI	Class I	Active
Eleos™	MS-050MM-02M	FDA UDI	Class II	Active
Eleos™	RT-20000-03N	FDA UDI	Class I	Active
ELEOS™ Limb Salvage System	RF-R004E-01M	FDA UDI	Class II	Active
Eleos™	KTAGW415E	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	imbc/ExSm	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	imcirpr	FDA UDI	Class II	Active
Eleos™	001-03-00004	FDA UDI	Class I	Active
ELEOS Limb Salvage System	FB-19152-03M	FDA UDI	Class II	Active
Eleos™	K0020211E	FDA UDI	Class I	Active
Eleos™	MT-00050-02N	FDA UDI	Class I	Active
Eleos™	KSP15140E	FDA UDI	Class II	Active
Eleos™	25102211E	FDA UDI	Class I	Active
Eleos™	K0001015E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	tmktp/Std20	FDA UDI	Class II	Active
Eleos™	K0053030E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	imtprmfh/ExSm	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	HB-2800R-03M	FDA UDI	Class II	Active
Eleos™	K0031001E	FDA UDI	Class I	Active
Eleos™	K0050516E	FDA UDI	Class I	Active
Eleos™	25000091E	FDA UDI	Class II	Active
Eleos™	18410135E	FDA UDI	Class I	Active
Eleos™	KSP18100E	FDA UDI	Class II	Active
Eleos™	2500SP18E	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	HC-10100-03M	FDA UDI	Class II	Active
Eleos™	25100091E	FDA UDI	Class I	Active
Eleos™	26000028E	FDA UDI	Class III	Active
Eleos™	25000011E	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	LS-50050-04M	FDA UDI	Class II	Active
Eleos™	KSC12100E	FDA UDI	Class II	Active
Eleos™	18056060E	FDA UDI	Class I	Active
Eleos™	K0001002E	FDA UDI	Class I	Active
Eleos™	K0000900E	FDA UDI	Class I	Active

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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