DEVICE: Accolade (04546540664457)

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Device Record History
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Device Identifier (DI) Information
Accolade
6720-0230
In Commercial Distribution
6720-0230
Howmedica Osteonics Corp.
04546540664457
GS1

1
058311945 *Terms of Use
132 Degree Neck Angle Hip Stem
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Device Characteristics
MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
33581 Coated hip femur prosthesis, modular
A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWL Prosthesis, hip, hemi-, femoral, metal
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Size: 2
Device Size Text, specify: Stem Length: 99.0 Millimeter
Device Size Text, specify: Neck Length: 30.0 Millimeter
Device Size Text, specify: Taper Connection: V40?
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Device Record Status
62ab4701-7cc3-4e19-b518-8879615e2b74
October 11, 2023
4
September 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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