OsseoFit™ Stemless Shoulder
OsseoFit is a stemless humeral implant system for anatomic total shoulder replacement. It combines a bone-anchoring humeral implant with an adapter that connects to the humeral head. The…
OsseoFit is a stemless humeral implant system for anatomic total shoulder replacement. It combines a bone-anchoring humeral implant with an adapter that connects to the humeral head.
The asymmetric anchor is specific to the left or right shoulder and has six fins of varying position, length and height. Anterior suture holes provide attachment points for soft tissue.
Inlay and Onlay Forms
Onlay implants sit on top of the prepared bone. Inlay implants have a dished upper portion and shorter fins so they sit within the bone. The two forms therefore establish different seating positions for the stemless anchor while retaining the humeral-head adapter connection.
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | PKC |
| Device type | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K241873 |
| Record published | 2024-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-5381-007-15 | Left Size 5 | In distribution |
| 00-5380-000-25 | Right Size 5 | In distribution |
| 00-5381-007-24 | Right Size 4 | In distribution |
| 00-5380-000-42 | Right Size 2 | In distribution |
| 00-5380-000-44 | Right Size 4 | In distribution |
| 00-5381-008-03 | Large | In distribution |
| 00-5380-000-31 | Left Size 1 | In distribution |
| 00-5381-007-22 | Right Size 2 | In distribution |
| 00-5381-007-25 | Right Size 5 | In distribution |
| 00-5380-000-43 | Right Size 3 | In distribution |
| 00-5380-000-41 | Right Size 1 | In distribution |
| 00-5380-000-21 | Right Size 1 | In distribution |
| 00-5381-007-14 | Left Size 4 | In distribution |
| 00-5380-000-34 | Left Size 4 | In distribution |
| 00-5381-007-11 | Left Size 1 | In distribution |
| 00-5380-000-32 | Left Size 2 | In distribution |
| 00-5380-000-14 | Left Size 4 | In distribution |
| 00-5380-000-45 | Right Size 5 | In distribution |
| 00-5381-010-22 | Right Large | In distribution |
| 00-5381-007-12 | Left Size 2 | In distribution |
| 00-5380-000-23 | Right Size 3 | In distribution |
| 00-5381-008-01 | Small | In distribution |
| 00-5380-000-22 | Right Size 2 | In distribution |
| 00-5380-000-33 | Left Size 3 | In distribution |
| 00-5380-000-24 | Right Size 4 | In distribution |
| 00-5381-010-12 | Left Large | In distribution |
| 00-5380-000-11 | Left Size 1 | In distribution |
| 00-5380-000-13 | Left Size 3 | In distribution |
| 00-5381-007-23 | Right Size 3 | In distribution |
| 00-5380-000-00 | In distribution | |
| 00-5381-008-02 | Medium | In distribution |
| 00-5380-000-35 | Left Size 5 | In distribution |
| 00-5381-007-13 | Left Size 3 | In distribution |
| 00-5381-007-21 | Right Size 1 | In distribution |
| 00-5381-010-21 | Right Small | In distribution |
| 00-5380-000-15 | Left Size 5 | In distribution |
| 00-5381-010-11 | Left Small | In distribution |
| 00-5380-000-12 | Left Size 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comprehensive® Shoulder System | Biomet Orthopedics | 83 |
| Equinoxe | Exactech, Inc. | 60 |
| SMR Stemless | Limacorporate | 51 |
| Global Icon | Depuy (Ireland) | 50 |
| Sidus® Stem-Free Shoulder | Zimmer, Inc. | 39 |
| DJO Surgical | Encore Medical, L.P. | 32 |
| Tornier Simpliciti® Shoulder System | Tornier Inc. | 27 |
| Simpliciti™ | Tornier Inc. | 27 |
| Arthrex® | Arthrex, Inc. | 21 |
| Tornier Perform | Tornier Inc. | 10 |
| FX V135 | Fx Solutions | 10 |
| Inhance | Depuy (Ireland) | 5 |
Showing 12 of 19. All products under Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241873 | 2024-12-11 |
| K171858 | 2017-12-18 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2019-08-21 | Class II | Labeling mix-ups | Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14. | 19 unit worldwide | 2020-07-20 |
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.