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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 59 of 99

Device	Model / Reference	Registries	Class	Status
UniSyn Hip System	4460-13642-B	FDA UDI	Class I	Active
Consensus Knee System/Revision Knee System/TaperSet Hip System	2810-0-0101	FDA UDI	Class I	Active
Consensus Knee System	2764-0-1002	FDA UDI	Class II	Active
Bipolar Hip System	1914-1-2255	FDA UDI	Class I	Active
Revision Knee System	2440-0-0512	FDA UDI	Class II	Active
Consensus Hip System	1705-0-2850	FDA UDI	Class II	Active
UniSyn Hip System	3442-44546-0	FDA UDI	Class II	Active
CS2 Acetabular System	1800-2-1248	FDA UDI	Class I	Active
Consensus Hip System	1800-1-0518	FDA UDI	Class I	Active
CKS Plus	2595-0-4021	FDA UDI	Class II	Active
CKS Plus	2344-0-1216	FDA UDI	Class II	Active
UniSyn Hip System	3461-42230-A	FDA UDI	Class II	Active
CS2 Hip System	1130-0-0020	FDA UDI	Class II	Active
CKS Plus	2597-0-6736	FDA UDI	Class II	Active
CS2 Hip System	1120-0-0011	FDA UDI	Class II	Active
Bipolar Hip System	1914-0-0058	FDA UDI	Class I	Active
Consensus Knee System	2940-0-3420	FDA UDI	Class I	Active
UniSyn Hip System	4462-43026-B	FDA UDI	Class I	Active
Consensus Knee System/Revision Knee System	2944-1-3412	FDA UDI	Class I	Active
Consensus Hip System	1020-0-4254	FDA UDI	Class II	Active
Revision Knee System	2440-0-1023	FDA UDI	Class II	Active
Consensus Knee System	2761-1-0003	FDA UDI	Class II	Active
Consensus Knee System	2582-0-0004	FDA UDI	Class II	Active
CKS Plus	2344-0-0014	FDA UDI	Class II	Active
Bipolar Hip System	1814-0-5759	FDA UDI	Class I	Active
CKS Plus	2596-0-6705	FDA UDI	Class II	Active
Consensus Knee System	2810-0-2052	FDA UDI	Class I	Active
CKS Plus	2341-0-0010	FDA UDI	Class II	Active
CKS Plus	2597-0-6003	FDA UDI	Class II	Active
TaperSet Hip System	1910-1-0003	FDA UDI	Class I	Active
UniSyn Hip System	4430-20205-B	FDA UDI	Class I	Active
UniSyn Hip System	4460-12017-A	FDA UDI	Class I	Active
UniSyn Hip System	3461-23034-A	FDA UDI	Class II	Active
Consensus Knee System	2252-1-0003	FDA UDI	Class II	Active
Consensus Knee System	2142-0-1216	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1007-0-2856	FDA UDI	Class II	Active
CKS Plus - VitalitE	2346-0-3420	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1006-0-3260	FDA UDI	Class II	Active
Unisyncase3	UNISYNCASE3	FDA UDI	Class I	Active
Consensus Knee System	2488-0-0006	FDA UDI	Class II	Active
CS2 Acetabular System	1905-1-0042	FDA UDI	Class I	Active
CKS Plus	2593-0-1003	FDA UDI	Class II	Active
Consensus Knee System	2241-0-0016	FDA UDI	Class II	Active
CKS Plus	2596-0-4722	FDA UDI	Class II	Active
UniSyn Hip System	4430-20220-A	FDA UDI	Class I	Active
UniSyn Hip System	3449-05400-0	FDA UDI	Class II	Active
CS2 Acetabular System	1731-0-3666	FDA UDI	Class I	Active
Tahoe Unicompartmental Knee System	3000-0-6416	FDA UDI	Class I	Active
Ambition Knee System	5110-0-0416	FDA UDI	Class II	Active
Consensus Hip System	1012-3-0018	FDA UDI	Class II	Active

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