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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 3 of 16

Device	Model / Reference	Registries	Class	Status
ELEOS Limb Salvage System	FB-20152-03M	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	LS-50046-04M	FDA UDI	Class II	Active
GenVie Magnesium Bone Scaffold	VF-005MG-00B	FDA UDI	Class II	Active
Eleos™	RT-09000-03N	FDA UDI	Class I	Active
Eleos™	KSP11140E	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	imtprhp/Std	FDA UDI	Class II	Active
ELEOS™ Limb Salvage System	TB-2202E-01M	FDA UDI	Class II	Active
Eleos™	002-03-00014	FDA UDI	Class I	Active
ELEOS™ Limb Salvage System	CB-17200-03M	FDA UDI	Class II	Active
Eleos™	25001208E	FDA UDI	Class II	Active
Eleos™	25107501E	FDA UDI	Class I	Active
Eleos™	2500CC17E	FDA UDI	Class II	Active
Eleos™	KSP20140E	FDA UDI	Class II	Active
Eleos™	KSP10100E	FDA UDI	Class II	Active
Eleos™	26010008E	FDA UDI	Class II	Active
Eleos™	K0051120E	FDA UDI	Class I	Active
Eleos™	K0001005E	FDA UDI	Class I	Active
Eleos™	25100070E	FDA UDI	Class I	Active
Eleos™	25102200E	FDA UDI	Class I	Active
Eleos™	25107804E	FDA UDI	Class I	Active
Eleos™	18811210E	FDA UDI	Class I	Active
Eleos™	K0053046E	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	CT-RFTB8-01N	FDA UDI	Class I	Active
Eleos™	K0056516E	FDA UDI	Class I	Active
Eleos™	2500BP20E	FDA UDI	Class II	Active
Eleos™	25000017E	FDA UDI	Class II	Active
Eleos™	K0011001E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	tmktp/ExSm5	FDA UDI	Class II	Active
Eleos™	K0051416E	FDA UDI	Class I	Active
Eleos™	BT-12152-03N	FDA UDI	Class I	Active
Eleos™	K0053034E	FDA UDI	Class I	Active
ELEOS Limb Salvage System	SB-4044V-03M	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	imtrfh	FDA UDI	Class II	Active
Eleos™	RG-RINGS-03N	FDA UDI	Class I	Active
Eleos Limb Salvage System With Nanocept Technology	AM-MS-070MF	FDA UDI	Class II	Active
Eleos™	KSP14140E	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	LS-50044-04M	FDA UDI	Class II	Active
Eleos™	SPSEB013E	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	TP-65180-04N	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	tmktp/Sm5	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	LS-50020-04M	FDA UDI	Class II	Active
Eleos™	KPTRTP32E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50028-04M	FDA UDI	Class II	Active
Eleos™	KTAGB115E	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	CS-65075-04M	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	HC-17120-03M	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	HB-4000R-03M	FDA UDI	Class II	Active
Eleos™	2510SL20E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	AM-M3DMD-04N	FDA UDI	Class II	Active
Eleos™	26010002E	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