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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 66 of 99

Device	Model / Reference	Registries	Class	Status
Consensus Hip System	1014-0-0052	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1716-0-0058	FDA UDI	Class III	Active
Consensus Knee System	2041-0-0012	FDA UDI	Class II	Active
Consensus Knee System	2041-0-1218	FDA UDI	Class II	Active
CKS Plus - VitalitE	2347-0-3418	FDA UDI	Class II	Active
CKS Plus	2598-0-6026	FDA UDI	Class II	Active
Revision Knee System	2975-0-0006	FDA UDI	Class I	Active
CS2 Acetabular System	1800-2-1255	FDA UDI	Class I	Active
Ambition Knee System	5100-0-1430	FDA UDI	Class II	Active
Consensus Knee System/Revision Knee System	2944-1-1222	FDA UDI	Class I	Active
TracOne Uni Knee System	2601-0-0000	FDA UDI	Class II	Active
CKS Plus	2598-0-6726	FDA UDI	Class II	Active
Consensus MBK System	2161-0-1214	FDA UDI	Class II	Active
Consensus Hip System	1703-0-0066	FDA UDI	Class III	Active
Ambition Knee System	5110-0-1412	FDA UDI	Class II	Active
Duraniom	2291-0-0000	FDA UDI	Class II	Active
Consensus Knee System	2251-1-0006	FDA UDI	Class II	Active
CKS Plus	2598-0-6006	FDA UDI	Class II	Active
Revision Knee System	2440-0-0501	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1188-0-3656	FDA UDI	Class II	Active
Consensus Knee System	2042-0-5616	FDA UDI	Class II	Active
Consensus Hip System	1017-1-2042	FDA UDI	Class II	Active
Tahoe Unicompartmental Knee System	3000-1-1605	FDA UDI	Class I	Active
Consensus Knee System	2810-0-1022	FDA UDI	Class I	Active
UniSyn Hip System	3425-11026-0	FDA UDI	Class II	Active
CKS Plus	2597-0-4324	FDA UDI	Class II	Active
Consensus Knee System	2042-0-3412	FDA UDI	Class II	Active
CKS - VitalitE	2043-0-3418	FDA UDI	Class II	Active
Consensus Hip System	1018-0-4547	FDA UDI	Class II	Active
CKS Plus	2598-0-4723	FDA UDI	Class II	Active
CKS Plus	2597-0-4710	FDA UDI	Class II	Active
CKS Plus	2595-0-6005	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1707-0-0048	FDA UDI	Class II	Active
Consensus Hip System	1017-0-1055	FDA UDI	Class II	Active
Consensus Hip System	0007-1-2202	FDA UDI	Class II	Active
CS2 Acetabular System	1905-1-0052	FDA UDI	Class I	Active
Consensus Knee System	2246-0-0022	FDA UDI	Class II	Active
Revision Knee System	2982-0-0005	FDA UDI	Class I	Active
CKS Plus - VitalitE	2345-0-1216	FDA UDI	Class II	Active
CKS Plus - VitalitE	2348-0-3412	FDA UDI	Class II	Active
Consensus Knee System	2141-0-5618	FDA UDI	Class II	Active
Consensus Hip System	1020-0-3853	FDA UDI	Class II	Active
TaperSet™ Reduced Distal Profile	1212-0-0105	FDA UDI	Class II	Active
Ambition Knee System	5110-0-0330	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1177-0-2864	FDA UDI	Class II	Active
Consensus Knee System	2142-0-1218	FDA UDI	Class II	Active
Consensus Knee System	2958-0-1301	FDA UDI	Class I	Active
Tahoe Uni Knee System	2260-0-0005	FDA UDI	Class II	Active
Consensus Knee System	2810-0-1303	FDA UDI	Class I	Active
CS2 Acet. Cup Sys. - VitalitE	1177-0-2856	FDA UDI	Class II	Active

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