Apex 3d S Total Ankle Replacement System
The short stem tibial component in the Apex 3D total ankle replacement range forms the tibial side of a fixed-bearing ankle prosthesis. The complete construct combines tibial and talar…
The short stem tibial component in the Apex 3D total ankle replacement range forms the tibial side of a fixed-bearing ankle prosthesis. The complete construct combines tibial and talar components with an ultra-high-molecular-weight polyethylene component, with sizes and configurations selected for patient anatomy.
The system is intended for ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis. It can be used in primary replacement and in revision surgery when sufficient bone stock remains. Components are intended for cemented use in the United States.
Listed Item
Short Stem Tibia, Tibia, FLAT, Short Stem (12X10.5MM Lattice), Right, Size 4, Long, 3DP – Sterile
Short Stem Design
The short stem tibial implant uses a central stem as its anterior fixation feature. Its tray retains the material, shape and dimensions of the earlier Apex 3D tibial trays, whose anterior fixation uses two pegs. The short stem therefore changes the tibial fixation configuration within the ankle system.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | Paragon 28, United States |
|---|---|
| FDA product code | HSN |
| Device type | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3110 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K240259 |
| Record published | 2024-09-17 |
| Record revised | 2026-02-09 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P11-181-BL1S-S | In distribution | |
| P11-180-BR2L-S | In distribution | |
| P11-181-BL6L-S | In distribution | |
| P11-181-BL1L-S | In distribution | |
| P11-180-BL4L-S | In distribution | |
| P11-180-BL2S-S | In distribution | |
| P11-180-BL4S-S | In distribution | |
| P11-851-P051 | In distribution | |
| P11-181-BL3L-S | In distribution | |
| P11-181-BL3S-S | In distribution | |
| P11-181-BL6S-S | In distribution | |
| P11-810-PLA6 | In distribution | |
| P11-180-BR3L-S | In distribution | |
| P11-810-PLF4 | In distribution | |
| P11-180-BL1L-S | In distribution | |
| P11-180-BR5L-S | In distribution | |
| P11-810-TUF4 | In distribution | |
| P11-180-BL3S-S | In distribution | |
| P11-810-PLF1 | In distribution | |
| P11-810-PLA3 | In distribution | |
| P11-854-D10T | In distribution | |
| P11-181-BL2L-S | In distribution | |
| P11-181-BL2S-S | In distribution | |
| P11-854-D09T | In distribution | |
| P11-180-BL10-S | In distribution | |
| P11-181-BR1S-S | In distribution | |
| P11-810-TUA6 | In distribution | |
| P11-180-BR6S-S | In distribution | |
| P11-180-BL3L-S | In distribution | |
| P11-181-BR2S-S | In distribution | |
| P11-810-TB34 | In distribution | |
| P11-180-BR3S-S | In distribution | |
| P11-180-BL6S-S | In distribution | |
| P11-180-BL1S-S | In distribution | |
| P11-810-TUA2 | In distribution | |
| P11-810-PLF2 | In distribution | |
| P11-181-BL10-S | In distribution | |
| P11-854-D09S | In distribution | |
| P11-181-BR6L-S | In distribution | |
| P11-181-BL5S-S | In distribution | |
| P11-810-TUA1 | In distribution | |
| P11-810-TUA4 | In distribution | |
| P11-810-TUF3 | In distribution | |
| P11-810-TUF2 | In distribution | |
| P11-181-BR4L-S | In distribution | |
| P11-851-TP56 | In distribution | |
| P11-180-BL5S-S | In distribution | |
| P11-810-TB56 | In distribution | |
| P11-810-TUA3 | In distribution | |
| P11-851-TP12 | In distribution | |
| P11-181-BR5S-S | In distribution | |
| P11-180-BL2L-S | In distribution | |
| P11-854-D12S | In distribution | |
| P11-181-BR6S-S | In distribution | |
| P11-181-BR5L-S | In distribution | |
| P11-810-PLA2 | In distribution | |
| P11-810-PLF3 | In distribution | |
| P11-181-BL4S-S | In distribution | |
| P11-180-BR5S-S | In distribution | |
| P11-180-BR2S-S | In distribution | |
| P11-180-BR1L-S | In distribution | |
| P11-180-BR4L-S | In distribution | |
| P11-181-BR4S-S | In distribution | |
| P11-181-BL4L-S | In distribution | |
| P11-181-BR3S-S | In distribution | |
| P11-181-BR1L-S | In distribution | |
| P11-180-BR6L-S | In distribution | |
| P11-180-BL5L-S | In distribution | |
| P11-810-PLF5 | In distribution | |
| P11-180-BR1S-S | In distribution | |
| P11-181-BR3L-S | In distribution | |
| P11-180-BR10-S | In distribution | |
| P11-810-PLF6 | In distribution | |
| P11-854-D10S | In distribution | |
| P11-810-PLA1 | In distribution | |
| P11-810-TUF6 | In distribution | |
| P11-181-BR2L-S | In distribution | |
| P11-181-BL5L-S | In distribution | |
| P11-810-TUF1 | In distribution | |
| P11-810-TUA5 | In distribution | |
| P11-810-TUF5 | In distribution | |
| P11-810-TB12 | In distribution | |
| P11-854-D12T | In distribution | |
| P11-181-BR10-S | In distribution | |
| P11-810-PLA5 | In distribution | |
| P11-180-BL6L-S | In distribution | |
| P11-180-BR4S-S | In distribution | |
| P11-851-TP34 | In distribution | |
| P11-810-PLA4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apex 3D Total Ankle Replacement System | Paragon 28 | 658 |
| Vantage | Exactech, Inc. | 362 |
| Cadence™ | Ascension Orthopedics, Inc. | 248 |
| Cadence Total Ankle System | Smith & Nephew, Inc. | 246 |
| Inbone | Wright Medical Technology, Inc. | 236 |
| Hintermann Series H2 | DT Medtech LLC | 225 |
| Infinity | Wright Medical Technology, Inc. | 220 |
| Incompass Total Ankle System | Wright Medical Technology, Inc. | 213 |
| Invision | Wright Medical Technology, Inc. | 186 |
| Kinos Axiom Instrumentation | restor3d, inc. | 169 |
| Quantum | In2Bones SAS | 157 |
| Hintermann Series H2 | Vilex LLC | 153 |
Showing 12 of 53. All products under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250641 | 2025-05-01 |
| K240259 | 2024-06-24 |
| K223227 | 2022-11-17 |
| K210390 | 2021-03-06 |
| K202019 | 2021-01-14 |
| K202373 | 2020-11-13 |
| K192994 | 2020-07-10 |
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.