DEVICE: ARCOS MODULAR REVISION HIP SYSTEM (00880304539259)
Device Identifier (DI) Information
ARCOS MODULAR REVISION HIP SYSTEM
11-302109
In Commercial Distribution
11-302109
Biomet Orthopedics, LLC
11-302109
In Commercial Distribution
11-302109
Biomet Orthopedics, LLC
No description.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| 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? |
|---|---|---|---|---|
| 34191 | Coated femoral stem prosthesis, modular |
A 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.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented |
| OQI | Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented |
| OQH | Hip, semi-constrained, cemented, metal/polymer + additive, cemented |
| 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 |
| JDG | Prosthesis, hip, femoral component, cemented, metal |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| PBI | prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K130063 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 25 MM |
Device Record Status
3d794283-3e94-42b9-9123-87742915347b
May 30, 2025
4
October 24, 2015
May 30, 2025
4
October 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
[?]
+1(800)348-9500
customerservice@zimmerbiomet.com
customerservice@zimmerbiomet.com