FDA.reportPublic FDA data

Revision Knee System

Primary DI
00840286843294
Brand
Revision Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2973-0-0006
Catalog number
2973-0-0006
Device description
RKS, Trial, Tibial Baseplate, Left, Size 6
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286843294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286843294008402868432948402868432940840286843294

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trial, reusableA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags#

DUNS number
085976260
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286841597Consensus Hip System/UniSyn Hip System4410-10020-A4410-10020-A2025-05-22
00840286841962Consensus Hip System1800-0-08401800-0-08402025-05-22
00840286843034Consensus Knee System/Revision Knee System2800-0-07052800-0-07052025-05-22
00840286847162Tahoe Unicompartmental Knee System3000-0-00793000-0-00792025-05-22
00840286847650Tahoe Unicompartmental Knee System3000-0-00733000-0-00732025-05-22
00840286847728Tahoe Unicompartmental Knee System3000-0-00613000-0-00612025-05-22
00840286853897Consensus Hip System1800-0-08451800-0-08452025-05-22
00840286855105Consensus Knee System/Revision Knee System2800-0-07062800-0-07062025-05-22
00840286855112Consensus Knee System/Revision Knee System2800-0-07072800-0-07072025-05-22
00840286855129Consensus Knee System/Revision Knee System2800-0-07082800-0-07082025-05-22
00840286855174CS2 Acetabular System1800-0-15221800-0-15222025-05-22
00840286840958TaperSet Hip System1910-0-00101910-0-00102025-05-21
00840286840996TaperSet Hip System1910-1-00121910-1-00122025-05-21
00840286845182Consensus Knee System2800-0-29502800-0-29502025-05-21
00840286845588Consensus Knee System2800-1-08002800-1-08002025-05-21
00840286840989Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System4410-20070-A4410-20070-A2025-05-14
00840286843959UniSyn Hip System4410-20031-A4410-20031-A2025-05-14
00840286855082Consensus Knee System/Revision Knee System2800-0-07012800-0-07012025-05-14
00840286855099Consensus Knee System/Revision Knee System2800-0-07022800-0-07022025-05-14
00840286855228CS2 Acetabular System1800-0-15281800-0-15282025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118131782LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
00888118131799LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
07640187463460POYA Medial TemplateBonebridge AGHWT2026-05-22
00888118145321PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00888118145338PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00889024706347OSS RS ROT Hinged Knee Provisional 20MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706354OSS RS ROT Hinged Knee Provisional 22MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706361OSS RS ROT Hinged Knee Provisional 14MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706378OSS RS ROT Hinged Knee Provisional 12MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706385OSS RS ROT Hinged Knee Provisional 16MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706392OSS RS ROT Hinged Knee Provisional 18MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706514REDUCED Z1 STD NECK TRL SZ 10-12Zimmer, Inc.HWT2026-03-19
00889024706521REDUCED Z1 STD NECK TRL SZ 0-9Zimmer, Inc.HWT2026-03-19
04046826472061MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472078MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472085MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
10885862609588VantageExactech, Inc.HWT2026-03-19
10885862648037EquinoxeExactech, Inc.HWT2026-03-19
10885862648044EquinoxeExactech, Inc.HWT2026-03-19
10885862648051EquinoxeExactech, Inc.HWT2026-03-19
10885862648068EquinoxeExactech, Inc.HWT2026-03-19
10885862648075EquinoxeExactech, Inc.HWT2026-03-19
10885862648082EquinoxeExactech, Inc.HWT2026-03-19
10885862659712N/AExactech, Inc.HWT2026-03-19
10885862659729N/AExactech, Inc.HWT2026-03-19
10885862659736N/AExactech, Inc.HWT2026-03-19
10885862659750N/AExactech, Inc.HWT2026-03-19
10885862659767N/AExactech, Inc.HWT2026-03-19
10885862659774N/AExactech, Inc.HWT2026-03-19
10885862659781N/AExactech, Inc.HWT2026-03-19