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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 47 of 99

Device	Model / Reference	Registries	Class	Status
UniSyn Hip System	4430-10028-A	FDA UDI	Class I	Active
Consensus Knee System	2251-1-0001	FDA UDI	Class II	Active
Consensus Knee System	55032-00	FDA UDI	Class I	Active
Consensus Hip System	2800-0-2225	FDA UDI	Class I	Active
TaperSet™ Reduced Distal Profile	1213-0-0165	FDA UDI	Class II	Active
CS2 Acetabular System	C1737	FDA UDI	Class I	Active
Consensus Knee System	2954-0-1101	FDA UDI	Class I	Active
Consensus Knee System	2353-0-0006	FDA UDI	Class II	Active
Consensus Hip System	1017-1-1052	FDA UDI	Class II	Active
Tahoe Uni Knee System	2061-0-0214	FDA UDI	Class II	Active
Consensus Knee System	2487-0-0006	FDA UDI	Class II	Active
Consensus Knee System	2451-1-0006	FDA UDI	Class II	Active
Consensus Knee System	2142-1-0020	FDA UDI	Class II	Active
CKS Plus	2342-0-3410	FDA UDI	Class II	Active
CKS Plus - VitalitE	2345-0-5612	FDA UDI	Class II	Active
Ambition Knee System	5100-0-1614	FDA UDI	Class II	Active
Consensus Knee System	2810-0-1026	FDA UDI	Class I	Active
UniSyn Hip System	3425-11226-0	FDA UDI	Class II	Active
Consensus Hip System	1800-1-0513	FDA UDI	Class I	Active
Consensus Knee System	2142-1-5612	FDA UDI	Class II	Active
Revision Knee System	2461-0-1118	FDA UDI	Class II	Active
Consensus Knee System	2487-0-0002	FDA UDI	Class II	Active
Consensus Knee System/Revision Knee System	2800-0-0500	FDA UDI	Class I	Active
TaperSet™ Hip System	1210-0-0135	FDA UDI	Class II	Active
CKS Plus	2587-0-1006	FDA UDI	Class II	Active
CKS Plus	2598-0-6013	FDA UDI	Class II	Active
CKS Plus	2594-0-1002	FDA UDI	Class II	Active
Consensus Knee System	2954-1-2003	FDA UDI	Class I	Active
Revision Knee System	2971-0-1110	FDA UDI	Class I	Active
Consensus Hip System	1705-0-3256	FDA UDI	Class II	Active
Consensus Hip System	1510-3-0010	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1177-0-3664	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1077-0-2848	FDA UDI	Class II	Active
CKS Plus	2597-0-6706	FDA UDI	Class II	Active
Consensus Knee System	2800-1-3903	FDA UDI	Class I	Active
UniSyn Hip System	3461-42422-A	FDA UDI	Class II	Active
CKS Plus	2597-0-6032	FDA UDI	Class II	Active
Consensus Knee System	2141-1-0018	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1725-0-3658	FDA UDI	Class II	Active
UniSyn Hip System	4430-20100-B	FDA UDI	Class I	Active
Ambition Knee System	5110-0-0310	FDA UDI	Class II	Active
Consensus Hip System	0005-0-3603	FDA UDI	Class II	Active
Consensus Hip System	1009-0-0014	FDA UDI	Class III	Active
Bipolar Hip System	1814-0-4244	FDA UDI	Class I	Active
Duraniom	2294-0-0005	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1722-0-3260	FDA UDI	Class II	Active
Consensus Hip System	1004-0-3262	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1718-0-0054	FDA UDI	Class III	Active
Consensus Hip System	0007-1-3603	FDA UDI	Class II	Active
Consensus Hip System	1017-1-1046	FDA UDI	Class II	Active

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