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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 44 of 99

Device	Model / Reference	Registries	Class	Status
CS2 Acet. Cup Sys. - VitalitE	1723-0-3256	FDA UDI	Class II	Active
Consensus Knee System	2487-0-0000	FDA UDI	Class II	Active
Consensus Hip System	1017-1-2051	FDA UDI	Class II	Active
TaperSet Hip System	1920-0-0185	FDA UDI	Class I	Active
Consensus Hip System	0007-0-2801	FDA UDI	Class II	Active
Consensus Knee System	2954-0-2303	FDA UDI	Class I	Active
CS2 Acet. Cup Sys. - VitalitE	1106-0-2852	FDA UDI	Class II	Active
Ambition Knee System	5100-0-0321	FDA UDI	Class II	Active
Revision Knee System	2471-0-0002	FDA UDI	Class II	Active
CKS Plus	2595-0-4006	FDA UDI	Class II	Active
CKS Plus	2598-0-6320	FDA UDI	Class II	Active
CKS Plus	2595-0-6014	FDA UDI	Class II	Active
CKS Plus	2588-0-1101	FDA UDI	Class II	Active
CS2 Acetabular System	1907-0-3252	FDA UDI	Class I	Active
UniSyn Hip System	3442-44534-A	FDA UDI	Class II	Active
UniSyn Hip System	3425-11231-0	FDA UDI	Class II	Active
CKS Plus	2598-0-6733	FDA UDI	Class II	Active
Consensus Knee System with TiNbN	2294-0-0005	FDA UDI	Class II	Active
Consensus Knee System/Revision Knee System	2943-1-1214	FDA UDI	Class I	Active
CKS Plus	2597-0-6300	FDA UDI	Class II	Active
Acetabular Shell	1701-0-0064	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1107-0-3256	FDA UDI	Class II	Active
Ambition Knee System	5100-0-0521	FDA UDI	Class II	Active
UniSyn Hip System	4430-20205-A	FDA UDI	Class I	Active
Ckscase7	CKSCASE7	FDA UDI	Class I	Active
CS2 Acetabular System	1727-0-2848	FDA UDI	Class I	Active
Ambition Knee System	5110-0-0625	FDA UDI	Class II	Active
Tahoe Unicompartmental Knee System	3060-0-0012	FDA UDI	Class I	Active
CS2 Acetabular System	1731-0-3662	FDA UDI	Class I	Active
Ambition Knee System	5110-0-1614	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1077-0-3254	FDA UDI	Class II	Active
Revision Knee System	2971-0-0820	FDA UDI	Class I	Active
Consensus Knee System	2481-0-0001	FDA UDI	Class II	Active
Consensus Hip System	1610-0-0015	FDA UDI	Class II	Active
Consensus Hip System	1020-0-3246	FDA UDI	Class II	Active
Consensus Knee System	2152-0-0003	FDA UDI	Class II	Active
CKS Plus	2597-0-6031	FDA UDI	Class II	Active
Consensus Knee System	2242-0-1216	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1106-0-2242	FDA UDI	Class II	Active
CKS Plus	2342-0-0012	FDA UDI	Class II	Active
Consensus Hip System	1800-1-0514	FDA UDI	Class I	Active
TracOne Uni Knee System	2602-0-0002	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1066-0-2862	FDA UDI	Class II	Active
Tahoe Uni Knee System	2061-0-0314	FDA UDI	Class II	Active
CKS Plus	2587-0-1002	FDA UDI	Class II	Active
Consensus MBK System	2552-0-0000	FDA UDI	Class II	Active
TracOne Uni Knee System	2602-0-0007	FDA UDI	Class II	Active
Ambition Knee System	5110-0-0412	FDA UDI	Class II	Active
Ambition Knee System	5100-0-0330	FDA UDI	Class II	Active
CKS Plus	2596-0-4024	FDA UDI	Class II	Active

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