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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 5 of 16

Device	Model / Reference	Registries	Class	Status
Eleos™	001-03-00013	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	PV-GUIDE-04N	FDA UDI	Class II	Active
Eleos™	BT-20152-03N	FDA UDI	Class I	Active
Eleos™	18052205E	FDA UDI	Class I	Active
Eleos™	K0051011E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	tmktp/Sm20	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	LS-50012-04M	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	SD-HAN14-01N	FDA UDI	Class I	Active
Eleos™	K0050018E	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	HR-THRDP-03N	FDA UDI	Class I	Active
Eleos™	K0050015E	FDA UDI	Class I	Active
Eleos™	KSP12100E	FDA UDI	Class II	Active
Eleos™	K0056512E	FDA UDI	Class I	Active
Eleos™	K0021012E	FDA UDI	Class I	Active
Eleos™	25100041E	FDA UDI	Class I	Active
Eleos™	25107000E	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	HB-GAG32-03N	FDA UDI	Class I	Active
Eleos™	BT-21152-03N	FDA UDI	Class I	Active
Eleos™	RT-11000-03N	FDA UDI	Class I	Active
Eleos™	001-03-00011	FDA UDI	Class I	Active
Eleos™	BP-1417M-03N	FDA UDI	Class I	Active
Eleos™	2500CP14E	FDA UDI	Class II	Active
Eleos™	KPTRTP38E	FDA UDI	Class I	Active
Eleos™	26012804E	FDA UDI	Class II	Active
Eleos™	K0053032E	FDA UDI	Class I	Active
Eleos™	18810220E	FDA UDI	Class I	Active
Eleos™	K0053027E	FDA UDI	Class I	Active
Eleos™	25100011E	FDA UDI	Class I	Active
Eleos™	002-03-00013	FDA UDI	Class I	Active
Eleos™	001-03-00006	FDA UDI	Class I	Active
Eleos™	001-03-00008	FDA UDI	Class I	Active
Eleos™	001-03-10014	FDA UDI	Class I	Active
Eleos™	K0002006E	FDA UDI	Class I	Active
Eleos™	25002113E	FDA UDI	Class II	Active
Eleos™	K0051020E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	DR-4325N-04N	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	CS-65120-04M	FDA UDI	Class II	Active
ELEOS™ Limb Salvage System	THSMWOS01M	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	CS-65060-04M	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	PB-3200R-03M	FDA UDI	Class II	Active
Eleos™	25001210E	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	TP-65025-04N	FDA UDI	Class II	Active
Eleos™	RT-12000-03N	FDA UDI	Class I	Active
Eleos™	K0053014E	FDA UDI	Class I	Active
Eleos™	SPSEB015E	FDA UDI	Class II	Active
Eleos™	KSP13140E	FDA UDI	Class II	Active
Eleos™	001-03-10009	FDA UDI	Class I	Active
Eleos™	2510SL10E	FDA UDI	Class I	Active
Eleos™	26012801E	FDA UDI	Class II	Active
Eleos™	001-03-10001	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