TheRay Collared and Collarless Femoral Stem

Primary DI
00816127025525
Brand
TheRay Collared and Collarless Femoral Stem
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
12-12-0001
Device description
Collarless Stem, Size 1, Standard, Forged
Published
2025-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

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
00816127025525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127025525008161270255258161270255250816127025525

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060211165
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816127025518TheRay Collared and Collarless Femoral Stem12-12-00002025-09-02
00816127025532TheRay Collared and Collarless Femoral Stem12-12-00022025-09-02
00816127025549TheRay Collared and Collarless Femoral Stem12-12-00032025-09-02
00816127025556TheRay Collared and Collarless Femoral Stem12-12-00042025-09-02
00816127025563TheRay Collared and Collarless Femoral Stem12-12-00052025-09-02
00816127025570TheRay Collared and Collarless Femoral Stem12-12-00062025-09-02
00816127025587TheRay Collared and Collarless Femoral Stem12-12-00072025-09-02
00816127025594TheRay Collared and Collarless Femoral Stem12-12-00082025-09-02
00816127025600TheRay Collared and Collarless Femoral Stem12-12-00092025-09-02
00816127025617TheRay Collared and Collarless Femoral Stem12-12-00102025-09-02
00816127025648TheRay Collared and Collarless Femoral Stem12-13-00002025-09-02
00816127025655TheRay Collared and Collarless Femoral Stem12-13-00012025-09-02
00816127025662TheRay Collared and Collarless Femoral Stem12-13-00022025-09-02
00816127025679TheRay Collared and Collarless Femoral Stem12-13-00032025-09-02
00816127025686TheRay Collared and Collarless Femoral Stem12-13-00042025-09-02
00816127025693TheRay Collared and Collarless Femoral Stem12-13-00052025-09-02
00816127025709TheRay Collared and Collarless Femoral Stem12-13-00062025-09-02
00816127025716TheRay Collared and Collarless Femoral Stem12-13-00072025-09-02
00816127025723TheRay Collared and Collarless Femoral Stem12-13-00082025-09-02
00816127025730TheRay Collared and Collarless Femoral Stem12-13-00092025-09-02

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Primary DI, Brand, Company table
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07611996074949SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
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07611996074963SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
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07611996075021SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
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07611996095609SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
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