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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 55 of 99

Device	Model / Reference	Registries	Class	Status
CKS Plus	2598-0-4705	FDA UDI	Class II	Active
Consensus Knee System	2571-0-0002	FDA UDI	Class II	Active
CKS Plus	2591-0-0100	FDA UDI	Class II	Active
Consensus Hip System	1703-0-0056	FDA UDI	Class III	Active
Revision Knee System	2412-0-0005	FDA UDI	Class II	Active
Consensus Hip System	1020-0-3250	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1725-0-3666	FDA UDI	Class II	Active
Consensus Hip System	1017-1-1047	FDA UDI	Class II	Active
CKS Plus	2597-0-4321	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1718-0-0066	FDA UDI	Class III	Active
CS2 Acetabular System	1726-0-2846	FDA UDI	Class I	Active
Consensus Knee System	2241-0-3410	FDA UDI	Class II	Active
Consensus Hip System	1017-0-2056	FDA UDI	Class II	Active
TracOne Uni Knee System	2602-0-0008	FDA UDI	Class II	Active
CKS Plus	2589-0-0001	FDA UDI	Class II	Active
UniSyn Hip System	3427-11314-0	FDA UDI	Class II	Active
Consensus Knee System	2930-1-1206	FDA UDI	Class I	Active
Consensus Knee System	2245-0-3418	FDA UDI	Class II	Active
CKS - VitalitE	2043-0-1218	FDA UDI	Class II	Active
CS2 Acetabular System	1727-0-2852	FDA UDI	Class I	Active
UniSyn Hip System	4460-11414-A	FDA UDI	Class I	Active
UniSyn Hip System	3461-42826-A	FDA UDI	Class II	Active
UniSyn Hip System	3441-13038-0	FDA UDI	Class II	Active
Consensus Knee System	2245-0-3412	FDA UDI	Class II	Active
Consensus MBK System	2162-0-1216	FDA UDI	Class II	Active
CKS - VitalitE	2144-0-5616	FDA UDI	Class II	Active
Consensus Hip System	1020-0-3239	FDA UDI	Class II	Active
UniSyn Hip System	4430-20095-A	FDA UDI	Class I	Active
Bipolar Hip System	1914-1-2245	FDA UDI	Class I	Active
Revision Knee System	2461-0-1510	FDA UDI	Class II	Active
Consensus Knee System	2957-0-1306	FDA UDI	Class I	Active
CKS Plus	2596-0-4302	FDA UDI	Class II	Active
Consensus Knee System	2660-0-6014	FDA UDI	Class II	Active
CKS Plus	2597-0-4034	FDA UDI	Class II	Active
CKS - VitalitE	2143-0-5622	FDA UDI	Class II	Active
Consensus Hip System	1705-0-2852	FDA UDI	Class II	Active
Consensus Hip System	1610-0-0009	FDA UDI	Class II	Active
Consensus Hip System	1020-0-1844	FDA UDI	Class II	Active
Consensus Hip System	1017-0-2044	FDA UDI	Class II	Active
Consensus Knee System with TiNbN	2293-0-0006	FDA UDI	Class II	Active
Revision Knee System	2980-0-0012	FDA UDI	Class I	Active
Bipolar Hip System	1914-0-0038	FDA UDI	Class I	Active
CKS Plus	2343-0-0016	FDA UDI	Class II	Active
Consensus Hip System	1012-3-0012	FDA UDI	Class II	Active
CS2 Acetabular System	55049-00	FDA UDI	Class I	Active
Consensus Knee System	2241-0-3420	FDA UDI	Class II	Active
Consensus Knee System with TiNbN	2289-0-0003	FDA UDI	Class II	Active
CKS Plus	2597-0-6726	FDA UDI	Class II	Active
CKS Plus	2344-0-1210	FDA UDI	Class II	Active
Consensus Knee System	2771-1-0003	FDA UDI	Class II	Active

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