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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 41 of 99

Device	Model / Reference	Registries	Class	Status
Ambition Knee System	5100-0-0412	FDA UDI	Class II	Active
Consensus Knee System	2761-1-0001	FDA UDI	Class II	Active
Consensus Hip System	1014-0-0040	FDA UDI	Class II	Active
UniSyn Hip System	4430-20185-B	FDA UDI	Class I	Active
Revision Knee System	2971-0-0822	FDA UDI	Class I	Active
CS2 Acet. Cup Sys. - VitalitE	1722-0-3258	FDA UDI	Class II	Active
Consensus Knee System	2242-0-0014	FDA UDI	Class II	Active
Consensus Hip System	1705-0-2652	FDA UDI	Class II	Active
Ambition Knee System	5110-0-1310	FDA UDI	Class II	Active
CKS Plus	2344-0-3418	FDA UDI	Class II	Active
CKS Plus	2596-0-6306	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1006-0-3666	FDA UDI	Class II	Active
Bipolar Hip System	1914-0-0060	FDA UDI	Class I	Active
TaperSet™ Hip System	1210-0-0165	FDA UDI	Class II	Active
CKS - VitalitE	2768-0-7501	FDA UDI	Class II	Active
CKS Plus	2596-0-4715	FDA UDI	Class II	Active
CKS Plus	2595-0-6710	FDA UDI	Class II	Active
CS2 Acetabular System/Consensus Hip System	1800-2-0622	FDA UDI	Class I	Active
CS2 Acetabular Cup System	1708-0-0068	FDA UDI	Class II	Active
CKS Plus	2591-0-1104	FDA UDI	Class II	Active
Consensus MBK System	2162-0-5612	FDA UDI	Class II	Active
Consensus Hip System	1710-0-0010	FDA UDI	Class II	Active
CKS Plus	2590-0-0003	FDA UDI	Class II	Active
Consensus Knee System	2954-0-1105	FDA UDI	Class I	Active
CKS Plus	2597-0-4021	FDA UDI	Class II	Active
CKS - VitalitE	2143-0-3416	FDA UDI	Class II	Active
Revision Knee System	2982-0-0003	FDA UDI	Class I	Active
TaperSet™ Reduced Distal Profile	1212-0-0135	FDA UDI	Class II	Active
UniSyn Hip System	4430-20210-A	FDA UDI	Class I	Active
CKS Plus	2596-0-4015	FDA UDI	Class II	Active
Ambition Knee System	5100-0-0514	FDA UDI	Class II	Active
Consensus Hip System	1410-2-0010	FDA UDI	Class II	Active
Consensus Knee System	2352-0-0002	FDA UDI	Class II	Active
Ambition Knee System	5100-0-0614	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1066-0-3248	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1107-0-3252	FDA UDI	Class II	Active
Consensus Hip System	0009-0-0015	FDA UDI	Class III	Active
Consensus Knee System	2041-0-5620	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1720-0-2852	FDA UDI	Class III	Active
Tahoe Unicompartmental Knee System	3000-0-1314	FDA UDI	Class I	Active
CS2 Acetabular System	1801-1-1215	FDA UDI	Class I	Active
Consensus Knee System	2940-0-1214	FDA UDI	Class I	Active
UniSyn Hip System	4430-20190-A	FDA UDI	Class I	Active
Consensus Hip System	2800-0-2040	FDA UDI	Class I	Active
UniSyn Hip System	4460-14546-B	FDA UDI	Class I	Active
UniSyn Hip System	3425-11621-0	FDA UDI	Class II	Active
Tahoe Uni Knee System	2061-0-0608	FDA UDI	Class II	Active
CKS Plus	2591-0-1100	FDA UDI	Class II	Active
Consensus Knee System	2660-0-5012	FDA UDI	Class II	Active
Consensus Knee System	2141-1-0020	FDA UDI	Class II	Active

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