DEVICE: Accolade (04546540664501)
Device Identifier (DI) Information
Accolade
6720-0737
In Commercial Distribution
6720-0737
Howmedica Osteonics Corp.
6720-0737
In Commercial Distribution
6720-0737
Howmedica Osteonics Corp.
132 Degree Neck Angle Hip Stem
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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Size: 7 |
| Device Size Text, specify: Stem Length: 114.0 Millimeter |
| Device Size Text, specify: Neck Length: 37.0 Millimeter |
| Device Size Text, specify: Taper Connection: V40? |
Device Record Status
5a5cf58b-f674-4185-a27b-9d3f8a971461
October 11, 2023
4
September 24, 2015
October 11, 2023
4
September 24, 2015
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined