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SHALBY ADVANCED TECHNOLOGIES, INC.

Last updated September 17, 2026

What SHALBY ADVANCED TECHNOLOGIES, INC. makes

Shalby Advanced Technologies, Inc. manufactures metallic and polyethylene components for knee and hip arthroplasty, including uncoated knee tibia prostheses, posterior-stabilized total knee prostheses, tibial inserts, and acetabular liners. Their portfolio also includes reusable trial components for knee and acetabular surgeries, as well as bipolar femoral head outer components for hemiarthroplasty. Specific systems include unicompartmental, revision, and total knee replacements, alongside modular hip prostheses.

The company’s devices are classified under FDA categories Class I, Class II, and Class III, with all products listed in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in the United States, where regulatory compliance follows FDA requirements for medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 1115 Windfield Way, El Dorado Hills, CA, 95762
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3020155054
DUNS Number: —

Catalogue (4950)

Page 46 of 99

Device	Model / Reference	Registries	Class	Status
CS2 Acetabular System	1729-0-3262	FDA UDI	Class I	Active
UniSyn Hip System	3422-11217-0	FDA UDI	Class II	Active
CKS Plus	2597-0-6034	FDA UDI	Class II	Active
CKS Plus	2596-0-6036	FDA UDI	Class II	Active
CKS Plus	2342-0-5616	FDA UDI	Class II	Active
Consensus Hip System	1020-0-2238	FDA UDI	Class II	Active
Consensus Hip System	1017-1-1041	FDA UDI	Class II	Active
TracOne Uni Knee System	2601-0-0005	FDA UDI	Class II	Active
Consensus Knee System	2142-1-3412	FDA UDI	Class II	Active
CKS Plus - VitalitE	2346-0-5612	FDA UDI	Class II	Active
Tahoe Uni Knee System	2060-0-0012	FDA UDI	Class II	Active
Consensus Hip System	1017-1-2040	FDA UDI	Class II	Active
CKS Plus	2591-0-0003	FDA UDI	Class II	Active
Tahoe Unicompartmental Knee System	3603-0-0102	FDA UDI	Class I	Active
Consensus Knee System	2142-0-5614	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1007-0-3254	FDA UDI	Class II	Active
Acetabular Shell	1701-0-0066	FDA UDI	Class II	Active
CKS Plus	2597-0-4315	FDA UDI	Class II	Active
Consensus Knee System	2353-0-0003	FDA UDI	Class II	Active
CKS Plus	2596-0-6013	FDA UDI	Class II	Active
CKS Plus	2596-0-4323	FDA UDI	Class II	Active
CKS Plus	2595-0-6703	FDA UDI	Class II	Active
Consensus Hip System	0005-0-3602	FDA UDI	Class II	Active
Consensus Knee System	2810-1-0301	FDA UDI	Class I	Active
CKS Plus	2341-0-0012	FDA UDI	Class II	Active
UniSyn Hip System	4460-13646-B	FDA UDI	Class I	Active
Consensus Knee System	2246-0-1212	FDA UDI	Class II	Active
Duraniom	2289-0-0001	FDA UDI	Class II	Active
UniSyn Hip System	4460-20033-A	FDA UDI	Class I	Active
CS2 Acetabular System	1800-0-1536	FDA UDI	Class I	Active
Consensus Knee System with TiNbN	2289-0-0002	FDA UDI	Class II	Active
CKS Plus	2589-0-1106	FDA UDI	Class II	Active
CKS Plus	2596-0-6335	FDA UDI	Class II	Active
Consensus Hip System	1014-0-0051	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1718-0-0060	FDA UDI	Class III	Active
Consensus Hip System	1010-3-0013	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1004-1-2854	FDA UDI	Class II	Active
Revision Knee System	2431-0-0002	FDA UDI	Class II	Active
Consensus Knee System	2940-0-5614	FDA UDI	Class I	Active
Consensus Knee System/Revision Knee System	2944-1-5614	FDA UDI	Class I	Active
UniSyn Hip System	3426-11816-0	FDA UDI	Class II	Active
TaperSet™ Reduced Distal Profile	1212-0-0240	FDA UDI	Class II	Active
Consensus Hip System	1410-0-0012	FDA UDI	Class II	Active
Consensus Knee System	2810-1-2202	FDA UDI	Class I	Active
Revision Knee System	2432-0-0003	FDA UDI	Class II	Active
Consensus Knee System	2572-0-0002	FDA UDI	Class II	Active
Consensus Knee System	2800-0-1053	FDA UDI	Class I	Active
CS2 Acet. Cup Sys. - VitalitE	1106-0-2866	FDA UDI	Class II	Active
UniSyn Hip System	4430-20170-B	FDA UDI	Class I	Active
Consensus MBK System	2161-0-3416	FDA UDI	Class II	Active

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