Titan™ Total Shoulder System
- Primary DI
- M269GLN092003000K1
- Brand
- Titan™ Total Shoulder System
- Company
- Ascension Orthopedics, Inc.
- Model
- GLN092003000K
- Catalog number
- GLN092003000K
- Device description
- The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal bodies, humeral stems, and humeral heads in the TITAN™ Modular Total Shoulder System for total replacement Arthroplasty and provide stable fixation, proximal bone loading, and proper head placement. The glenoid component is intended for use of correction of humeral joint due to severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. The component is also used in repairing fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory as well as other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component).
- Published
- 2017-10-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K142413 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780120155 | Primary | GS1 | 0 | |
| M269GLN092003000K1 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780120155 | 10381780120155 |
GMDN Terms#
| Term | Definition |
|---|---|
| Shoulder glenoid fossa prosthesis, prefabricated | An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 942377524
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
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|---|---|---|---|---|
| 10381780240310 | Cadence™ | 10203193 | 2016-08-24 | |
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| 10381780245629 | Titan™ | IP0920055001 | IMP-0920-055-001 | 2017-09-05 |
| 10381780245636 | Titan™ | IP0920064001 | IMP-0920-064-001 | 2017-09-05 |
| 10381780245643 | Titan™ | IP0920079501 | IMP-0920-0795-01 | 2017-09-05 |
| 10381780245650 | Titan™ | IMP096006401 | IMP-0960-064-01 | 2017-09-05 |
| 10381780245667 | Titan™ | IMP096006601 | IMP-0960-066-01 | 2017-09-05 |
| 10381780245674 | Titan™ | IMP096007101 | IMP-0960-071-01 | 2017-09-05 |
| 10381780245681 | Ascension® | IMP10000D | IMP-100-00D | 2017-09-05 |
| 10381780245698 | Ascension® | IMP10000P | IMP-100-00P | 2017-09-05 |
| 10381780245704 | Integra® | IMP20000D | IMP-200-00D | 2017-09-05 |
| 10381780245711 | Integra® | IMP20000P | IMP-200-00P | 2017-09-05 |
| 10381780245728 | Integra® | IMP30000 | IMP-300-00 | 2017-09-05 |
| 10381780245735 | Integra® | IMP35000 | IMP-350-00 | 2017-09-05 |
| 10381780245759 | NuGrip® CMC Implant System | IMP44200 | IMP-442-00 | 2017-09-05 |
| 10381780245766 | First Choice® DRUJ System | IMP60000 | IMP-600-00 | 2017-09-05 |
| 10381780245780 | Movement® | IMP-890-00MT | IMP-890-00MT | 2017-09-05 |
| 10381780245797 | Movement® | IMP-890-00PP | IMP-890-00PP | 2017-09-05 |
| 10381780245803 | Integra® | IMP90001 | IMP-900-01 | 2017-09-05 |
| 10381780245988 | Integra® | MAL092008501 | MAL-0920-085-01 | 2017-08-30 |
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