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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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Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3020155054
DUNS Number: —

Catalogue (4950)

Page 70 of 99

Device	Model / Reference	Registries	Class	Status
Revision Knee System	2976-0-0001	FDA UDI	Class I	Active
Bipolar Hip System	1914-1-2254	FDA UDI	Class I	Active
Consensus Hip System	1705-0-2848	FDA UDI	Class II	Active
Consensus Knee System	2451-0-0004	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1177-0-3262	FDA UDI	Class II	Active
CKS Plus	2594-0-0000	FDA UDI	Class II	Active
Consensus Knee System	2246-0-3420	FDA UDI	Class II	Active
Consensus Knee System	2761-0-0004	FDA UDI	Class II	Active
Consensus Hip System	1705-0-2656	FDA UDI	Class II	Active
CKS Plus	2598-0-4300	FDA UDI	Class II	Active
CKS - VitalitE	2143-0-3422	FDA UDI	Class II	Active
Rkscase2	RKSCASE2	FDA UDI	Class I	Active
Consensus Hip System	1014-0-0060	FDA UDI	Class II	Active
Consensus Knee System/Revision Knee System	2943-1-3418	FDA UDI	Class I	Active
CKS Plus	2596-0-4312	FDA UDI	Class II	Active
Ambition Knee System	5100-0-1314	FDA UDI	Class II	Active
UniSyn Hip System	4460-11716-A	FDA UDI	Class I	Active
CKS Plus	2589-0-1104	FDA UDI	Class II	Active
Consensus Knee System	2941-0-3410	FDA UDI	Class I	Active
UniSyn Hip System	3461-23238-A	FDA UDI	Class II	Active
CKS Plus	2598-0-6316	FDA UDI	Class II	Active
Revision Knee System	2471-0-0001	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1166-0-3248	FDA UDI	Class II	Active
Consensus MBK System	2161-0-3410	FDA UDI	Class II	Active
UniSyn Hip System	3473-22800-0	FDA UDI	Class II	Active
Consensus Knee System	2354-0-0004	FDA UDI	Class II	Active
Consensus Knee System	2041-0-3410	FDA UDI	Class II	Active
CKS - VitalitE	2044-0-3412	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1006-0-3662	FDA UDI	Class II	Active
CKS Plus	2342-0-3416	FDA UDI	Class II	Active
Revision Knee System	2971-0-1510	FDA UDI	Class I	Active
Consensus Hip System	1004-0-3260	FDA UDI	Class II	Active
Consensus Knee System	2800-0-1710	FDA UDI	Class I	Active
CS2 Acetabular System	1907-0-3662	FDA UDI	Class I	Active
CKS Plus	2596-0-4703	FDA UDI	Class II	Active
UniSyn Hip System	3422-11820-0	FDA UDI	Class II	Active
Duraniom	2291-0-0001	FDA UDI	Class II	Active
UniSyn Hip System	4410-20040-A	FDA UDI	Class I	Active
UniSyn Hip System	3473-22400-0	FDA UDI	Class II	Active
CKS Plus	2595-0-6720	FDA UDI	Class II	Active
Consensus Knee System/Revision Knee System	2943-1-3414	FDA UDI	Class I	Active
Consensus Knee System	2800-0-1250	FDA UDI	Class I	Active
Consensus Knee System	2253-0-0005	FDA UDI	Class II	Active
Consensus Hip System	1704-0-0056	FDA UDI	Class III	Active
Consensus Knee System/Revision Knee System	2800-0-0432	FDA UDI	Class I	Active
Consensus Knee System with TiNbN	2292-0-0002	FDA UDI	Class II	Active
Consensus Knee System	2800-1-1206	FDA UDI	Class I	Active
Revision Knee System	2971-0-1122	FDA UDI	Class I	Active
CKS - VitalitE	2144-0-1214	FDA UDI	Class II	Active
CKS Plus - VitalitE	2345-0-1218	FDA UDI	Class II	Active

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