FDA.reportPublic FDA data

Modular Radial Head (MRH) System

Primary DI
00885556857496
Brand
Modular Radial Head (MRH) System
Company
Smith & Nephew, Inc.
Model
TRL-351-20L
Catalog number
TRL-351-20L
Device description
MRH TRIAL. TI. SZ. 20L
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032686000ASCENSION MODULAR RADIAL HEADAscension Orthopedics, Inc.2003-10-22KWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556857496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556857496008855568574968855568574960885556857496

GMDN Terms#

Term, Definition table
TermDefinition
Elbow radius prosthesis trialA copy of a final elbow radius prosthesis designed to be used for trial reductions during elbow arthroplasty to help determine the correct size, length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556830543PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00885556830550PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00885556830567PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00885556830574PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00888867570764Arthrex®ARTHREX, INC.KWI2026-09-21
00888867570771Arthrex®ARTHREX, INC.KWI2026-09-21
00888867568044Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568051Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568068Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568075Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568082Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568099Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568129Arthrex®ARTHREX, INC.KWI2026-09-17
00885556827307Katalyst Bipolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
00885556827314Katalyst Bipolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
00885556827338Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
00885556827345Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
10886982300713NASynthes GmbHKWI2020-06-17
10886982300522NASynthes GmbHKWI2020-06-08
10886982300539NASynthes GmbHKWI2020-06-08
10886982300546NASynthes GmbHKWI2020-06-08
10886982300553NASynthes GmbHKWI2020-06-08
10886982300560NASynthes GmbHKWI2020-06-08
10886982300577NASynthes GmbHKWI2020-06-08
10886982300584NASynthes GmbHKWI2020-06-08
10886982300591NASynthes GmbHKWI2020-06-08
10886982300607NASynthes GmbHKWI2020-06-08
10886982300614NASynthes GmbHKWI2020-06-08
10886982300621NASynthes GmbHKWI2020-06-08
10886982300638NASynthes GmbHKWI2020-06-08