Titan™ Total Shoulder System
TITAN is a modular shoulder replacement family combining metaphyseal bodies, humeral stems, humeral heads and polyethylene glenoid components. A humeral body, stem and head can form a…
TITAN is a modular shoulder replacement family combining metaphyseal bodies, humeral stems, humeral heads and polyethylene glenoid components. A humeral body, stem and head can form a hemiarthroplasty when the natural glenoid provides a suitable bearing surface.
Adding a glenoid component creates a total shoulder replacement. The humeral bodies and stems vary in length and have a proximal shape designed for fixation within the natural humeral geometry.
Listed Item
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).
Articulation and Fixation Options
Heads are available with concentric or eccentric articulating surfaces. Polyethylene glenoids have keeled or three-peg designs and work with either head form; a listed pegged glenoid is one example. Humeral components support cemented or uncemented use, while glenoid components require cement.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Manufacturer |
| 510(k) | K142413 |
| Record published | 2017-10-09 |
| Record revised | 2025-03-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M9200105019E | .748 in H x 1.999 in dia | In distribution |
| MHH-0923-010-4015E | .591 in H x 1.608 in dia | In distribution |
| M9200104416C | .630 in H x 1.768 in dia | In distribution |
| GLN092003000P | Size Extra Small | In distribution |
| M9200104815E | .591 in H x 1.946 in dia | In distribution |
| BOD-0923-020-14STD | 14 Standard | In distribution |
| M9200105019C | .748 in H x 1.999 in dia | In distribution |
| M9200104818C | .709 in H x 1.922 in dia | In distribution |
| BSW092002101 | 1.0 in L x.186 in dia | In distribution |
| MHH-0923-010-5022E | .866 in H x 1.983 in dia | In distribution |
| SEM092002510 | 3.86 in L x.432 in dia; Size 10 | In distribution |
| GLN092003001P | Size Small | In distribution |
| MHH-0923-010-5019C | .748 in H x 1.999 in dia | In distribution |
| BOD-0923-020-10LRG | 10 Large | In distribution |
| M9200104614C | .551 in H x 1.872 in dia | In distribution |
| BOD-0923-020-14SML | 14 Small | In distribution |
| M9200104620E | .787 in H x 1.827 in dia | In distribution |
| MHH-0923-010-5220C | .787 in H x 2.075 in dia | In distribution |
| M9200104614E | .551 in H x 1.872 in dia | In distribution |
| BOD-0923-020-12STD | 12 Standard | In distribution |
| M9200104620C | .787 in H x 1.827 in dia | In distribution |
| MHH-0923-010-4216E | .630 in H x 1.685 in dia | In distribution |
| GLN092003001K | Size Small | In distribution |
| SEM092002508 | 3.86 in L x.356 in dia; Size 08 | In distribution |
| M9200105220C | .787 in H x 2.075 in dia | In distribution |
| BOD-0923-021-08SML | 08 Small | In distribution |
| SEM092002515 | 3.86 in L x.644 in dia; Size 15 | In distribution |
| MHH-0923-010-4620E | .787 in H x 1.827 in dia | In distribution |
| MHH-0923-010-5022C | .866 in H x 1.983 in dia | In distribution |
| M9200105022E | .866 in H x 1.983 in dia | In distribution |
| BSW092001NS | 1.00 in L x.186 in dia | In distribution |
| SEM095002512 | 3.86 in L x.470 in dia; Size 12 | In distribution |
| B92002014SML | 14 Small | In distribution |
| M9200104419C | .748 in H x 1.749 in dia | In distribution |
| B92002008STD | 08 Standard | In distribution |
| SEM095002514 | 3.86 in L x.550 in dia; Size 14 | In distribution |
| MHH-0923-010-5220E | .787 in H x 2.075 in dia | In distribution |
| GLN092003003K | Size Large | In distribution |
| SEM095002508 | 3.86 in L x.320 in dia; Size 08 | In distribution |
| M9200104821E | .827 in H x 1.904 in dia | In distribution |
| MHH-0923-010-4614E | .551 in H x 1.872 in dia | In distribution |
| MHH-0923-010-4419E | .748 in H x 1.749 in dia | In distribution |
| SEM092002509 | 3.86 in L x.389 in dia; Size 09 | In distribution |
| M9200104821C | .827 in H x 1.904 in dia | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152047 | 2015-12-23 |
| K142413 | 2014-11-14 |
| K100448 | 2010-08-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.