FDA.reportPublic FDA data

TheRay Collared and Collarless Femoral Stem

Primary DI
00816127026522
Brand
TheRay Collared and Collarless Femoral Stem
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
12-80-0002
Device description
Femoral Broach, Collared Stem, Size 2
Published
2024-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTQBroach

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241875000TheRay Collared and Collarless Femoral StemNextstep Arthropedix2024-09-13MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816127026522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127026522008161270265228161270265220816127026522

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
060211165
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810030810575InSitu Hip System10-83-04572026-06-01
00810030810582InSitu Hip System10-83-04582026-06-01
00810030810599InSitu Hip System10-83-04592026-06-01
00810030810605InSitu Hip System10-83-04602026-06-01
00810030810612InSitu Hip System10-83-04612026-06-01
00810030810629InSitu Hip System10-83-04622026-06-01
00810030810636InSitu Hip System10-83-04632026-06-01
00810030810643InSitu Hip System10-83-04642026-06-01
00810030810650InSitu Hip System10-83-04652026-06-01
00810030810667InSitu Hip System10-83-04662026-06-01
00810030810674InSitu Hip System10-83-04672026-06-01
00810030810681InSitu Hip System10-83-04682026-06-01
00810030810698InSitu Hip System10-83-04692026-06-01
00810030810704InSitu Hip System10-83-04702026-06-01
00810030811657InSitu Hip System10-95-2081-452026-06-01
00810030811671InSitu Hip System10-95-2081-602026-06-01
00810030811992InSitu Hip System10-85-36482026-06-01
00810030812036InSitu Hip System10-84-20422026-06-01
00810030812043InSitu Hip System10-84-20442026-06-01
00810030812050InSitu Hip System10-84-20462026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094692803Klassic Blade Femoral Broach, Line-To-Line, size 0TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692810Klassic Blade Femoral Broach, Line-To-Line, size 1TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692827Klassic Blade Femoral Broach, Line-To-Line, size 2TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692834Klassic Blade Femoral Broach, Line-To-Line, size 3TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692841Klassic Blade Femoral Broach, Line-To-Line, size 4TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692858Klassic Blade Femoral Broach, Line-To-Line, size 5TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692865Klassic Blade Femoral Broach, Line-To-Line, size 6TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692872Klassic Blade Femoral Broach, Line-To-Line, size 7TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692889Klassic Blade Femoral Broach, Line-To-Line, size 8TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692896Klassic Blade Femoral Broach, Line-To-Line, size 9TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692902Klassic Blade Femoral Broach, Line-To-Line, size 10TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692919Klassic Blade Femoral Broach, Line-To-Line, size 11TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692926Klassic Blade Femoral Broach, Line-To-Line, size 12TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00840314269751gSourceGSOURCE LLCHTQ2025-06-16
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00885556871454AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556871461AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556871478AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556871485AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556856505Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856512Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856529Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856536Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856543Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856550Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856567Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856574Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856581Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856598Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856604Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02