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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 34 of 99

Device	Model / Reference	Registries	Class	Status
Ambition Knee System	5100-0-1530	FDA UDI	Class II	Active
CKS Plus	2596-0-4713	FDA UDI	Class II	Active
UniSyn Hip System	3461-52830-A	FDA UDI	Class II	Active
Tahoe Unicompartmental Knee System	3000-1-1705	FDA UDI	Class I	Active
CKS Plus	2598-0-6312	FDA UDI	Class II	Active
Consensus Knee System	2581-0-0000	FDA UDI	Class II	Active
CKS Plus	2596-0-6316	FDA UDI	Class II	Active
UniSyn Hip System	4460-11326-A	FDA UDI	Class I	Active
Revision Knee System	2974-0-0006	FDA UDI	Class I	Active
Consensus Knee System	2762-2-0003	FDA UDI	Class II	Active
CKS Plus	2598-0-6711	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1006-0-2864	FDA UDI	Class II	Active
Consensus Hip System	0006-0-2801	FDA UDI	Class II	Active
Consensus Hip System	1610-2-0009	FDA UDI	Class II	Active
TaperSet™ Hip System	1210-0-0105	FDA UDI	Class II	Active
CKS Plus	2343-0-5622	FDA UDI	Class II	Active
Consensus Knee System	2142-1-0018	FDA UDI	Class II	Active
Consensus Hip System	1014-0-0055	FDA UDI	Class II	Active
Consensus Knee System	2810-0-1028	FDA UDI	Class I	Active
CKS - VitalitE	2043-0-5616	FDA UDI	Class II	Active
Consensus Hip System	0007-1-2804	FDA UDI	Class II	Active
Consensus Knee System	2581-0-0005	FDA UDI	Class II	Active
Revision Knee System	2971-0-0812	FDA UDI	Class I	Active
CKS Plus	2596-0-6023	FDA UDI	Class II	Active
CKS Plus	2343-0-1218	FDA UDI	Class II	Active
UniSyn Hip System	4430-20115-B	FDA UDI	Class I	Active
Consensus Knee System	2772-2-0003	FDA UDI	Class II	Active
Consensus Hip System	1703-0-0060	FDA UDI	Class III	Active
UniSyn Hip System	3461-53230-A	FDA UDI	Class II	Active
CS2 Acetabular System	1728-0-3264	FDA UDI	Class I	Active
Consensus Knee System	2800-1-0800	FDA UDI	Class I	Active
CKS Plus	2595-0-6336	FDA UDI	Class II	Active
Consensus Knee System	2766-0-1003	FDA UDI	Class II	Active
Consensus Knee System	2954-0-2306	FDA UDI	Class I	Active
UniSyn Hip System	3425-11921-0	FDA UDI	Class II	Active
UniSyn Hip System	4462-42226-B	FDA UDI	Class I	Active
Consensus Hip System	2800-0-2212	FDA UDI	Class I	Active
Consensus Knee System	2252-1-0005	FDA UDI	Class II	Active
UniSyn Hip System	4460-11615-A	FDA UDI	Class I	Active
Consensus Knee System	2242-0-1210	FDA UDI	Class II	Active
TaperSet™ Reduced Distal Profile	1212-0-0120	FDA UDI	Class II	Active
Consensus MBK System	2161-0-0014	FDA UDI	Class II	Active
CS2 Acetabular System	1800-0-0860	FDA UDI	Class I	Active
CKS Plus	2588-0-0101	FDA UDI	Class II	Active
Consensus Hip System	1020-0-1244	FDA UDI	Class II	Active
CKS Plus - VitalitE	2346-0-3410	FDA UDI	Class II	Active
CKS Plus	2596-0-6701	FDA UDI	Class II	Active
Tahoe Uni Knee System	2060-0-0114	FDA UDI	Class II	Active
CKS - VitalitE	2043-0-0016	FDA UDI	Class II	Active
Tahoe Unicompartmental Knee System	3000-1-1703	FDA UDI	Class I	Active

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