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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 8 of 16

Device	Model / Reference	Registries	Class	Status
Eleos™	25004009E	FDA UDI	Class II	Active
Eleos™	2500SP16E	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	mktp/Sm15	FDA UDI	Class II	Active
Eleos™	18052206E	FDA UDI	Class I	Active
Eleos™	001-03-00016	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	PL-PLANE-03N	FDA UDI	Class I	Active
Eleos™	K0051023E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	DG-LS040-04N	FDA UDI	Class II	Active
Eleos™	25100017E	FDA UDI	Class I	Active
ELEOS™ Limb Salvage System	001-03-00021	FDA UDI	Class I	Active
Eleos™	25104011E	FDA UDI	Class I	Active
Eleos™	PT-20000-02M	FDA UDI	Class II	Active
Eleos™	RT-18000-03N	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50035-04M	FDA UDI	Class II	Active
Eleos™	K0031013E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	SMLTBC00	FDA UDI	Class II	Active
Eleos™	25102303E	FDA UDI	Class I	Active
Eleos™	001-03-10013	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	HY-RULPF-03N	FDA UDI	Class I	Active
Eleos™	RT-18500-03N	FDA UDI	Class I	Active
Eleos™	25001216E	FDA UDI	Class II	Active
Eleos™	BT-11255-03N	FDA UDI	Class I	Active
ELEOS Limb Salvage System	CB-15152-03M	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	impbimp/ExSm	FDA UDI	Class II	Active
Eleos™	25002100E	FDA UDI	Class II	Active
Eleos™	KTAGB405E	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	HC-13120-03M	FDA UDI	Class II	Active
Eleos™	K0056518E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50022-04M	FDA UDI	Class II	Active
Eleos™	001-03-00015	FDA UDI	Class I	Active
Eleos™	PF-TRLRL-02N	FDA UDI	Class I	Active
Eleos™	18056063E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	SMMLTBC00-MK3	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	CS-65030-04M	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	HB-GAG28-03N	FDA UDI	Class I	Active
Eleos™	KTAGB205E	FDA UDI	Class II	Active
Eleos™	K0053038E	FDA UDI	Class I	Active
Eleos™	K0053033E	FDA UDI	Class I	Active
Eleos™	K0051413E	FDA UDI	Class I	Active
Eleos™	K0050522E	FDA UDI	Class I	Active
Eleos™	K0053037E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	imtprmfh/Sm	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	tmktp/ExSm20	FDA UDI	Class II	Active
Eleos™	MS-040MM-02M	FDA UDI	Class II	Active
Eleos™	K0051018E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	CS-65065-04M	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	LS-50070-04M	FDA UDI	Class II	Active
Eleos™	25107600E	FDA UDI	Class I	Active
Eleos™	K0031002E	FDA UDI	Class I	Active
Eleos™	25001110E	FDA UDI	Class II	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