Titan™ Total Shoulder System
Basic Information
- Brand Name
- Titan™ Total Shoulder System
- Primary DI
- 10381780120209
- Version / Model
- GLN092003002P
- Catalog Number
- GLN092003002P
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-09
- Public Version
- 5
- Public Version Date
- 2023-01-25
- Public Version Status
- Update
- Public Device Record Key
- 1b89a3a8-8139-442b-9f51-3e37c3607290
- Distribution End Date
- 2026-12-31
Device Description
The Titan Modular Total Shoulder System Pegged 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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | Orthopedic | 888.3690 | 2 |
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62467 | Surgical soft-tissue manipulation forceps, alligator, reusable | A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780120209 | GS1 | ||||
| Secondary | M269GLN092003002P1 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142413 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size Medium |