Quantum
Quantum is a fixed-bearing total ankle prosthesis for primary or revision ankle replacement in patients whose ankle joints are damaged by severe rheumatoid, post-traumatic, or degenerative…
Quantum is a fixed-bearing total ankle prosthesis for primary or revision ankle replacement in patients whose ankle joints are damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. In the United States, the filing states that the prosthesis is intended for cement use only.
The prosthesis has a tibial implant, tibial inlay, and talar implant. The tibial and talar implants are secured to the patient’s anatomy with bone cement, and the inlay is fixed to the tibial implant during surgery. The inlay acts as a bearing along the talar implant.
Listed Item
Quantum PSI Guides FOR Total Ankle Replacement, US
Components and Fixation
The filing describes the three components and how they are fixed in place and interact in the replaced joint.
1manufacturer
157catalogue numbers in this listing
4510(k) clearances naming this product code
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 | In2Bones SAS, France |
|---|---|
| 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, Manufacturer, Exporter |
| 510(k) | K191380 |
| Record published | 2020-07-24 |
| Record revised | 2025-12-15 (version 5) |
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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 26 to 3303 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M50 SU121 | Length 31.58 mm | In distribution |
| M50 SU221 | Length 31.58 mm | In distribution |
| M50 ST220 | Length 31.58 mm | In distribution |
| M50 SU112 | Length 29.49 mm | In distribution |
| M50 SU225 | Length 31.58 mm | In distribution |
| M50 SU119 | Length 29.49 mm | In distribution |
| M50 SU147 | Length 37.51 mm | In distribution |
| M50 SU126 | Length 31.58 mm | In distribution |
| M50 ST240 | Length 37.51 mm | In distribution |
| M50 SU157 | Length 40.57 mm | In distribution |
| M50 SU111 | Length 29.49 mm | In distribution |
| M50 SU237 | Length 34.47 mm | In distribution |
| M50 SC276 | In distribution | |
| M50 SU153 | Length 40.57 mm | In distribution |
| M50 SC135 | Length 41.70 mm | In distribution |
| M50 ST261 | Length 46.51 mm | In distribution |
| M50 SU243 | Length 37.51 mm | In distribution |
| M50 SU129 | Length 31.58 mm | In distribution |
| M50 SU133 | Length 34.47 mm | In distribution |
| M50 SU122 | Length 31.58 mm | In distribution |
| M50 SU215 | Length 29.49 mm | In distribution |
| M50 SC242 | Length 28.86 mm | In distribution |
| M50 SC246 | Length 44.45 mm | In distribution |
| M50 SC132 | Length 33.27 mm | In distribution |
| M50 SC235 | Length 41.70 mm | In distribution |
| M50 SU241 | Length 37.51 mm | In distribution |
| M50 ST250 | Length 40.57 mm | In distribution |
| M50 SU267 | Length 43.51 mm | In distribution |
| M50 SU158 | Length 40.57 mm | In distribution |
| M50 SU218 | Length 29.49 mm | In distribution |
| M50 ST260 | Length 43.51 mm | In distribution |
| M50 SU268 | Length 43.51 mm | In distribution |
| M50 SU248 | Length 37.51 mm | In distribution |
| M50 SC241 | Length 31.40 mm | In distribution |
| M50 SU249 | Length 37.51 mm | In distribution |
| M50 ST111 | Length 32.49 mm | In distribution |
| M50 SU252 | Length 40.57 mm | In distribution |
| M50 SU135 | Length 34.47 mm | In distribution |
| M50 ST151 | Length 43.57 mm | In distribution |
| M50 SU165 | Length 43.51 mm | In distribution |
| M50 ST141 | Length 40.51 mm | In distribution |
| M50 SU265 | Length 43.51 mm | In distribution |
| M50 SU139 | Length 34.47 mm | In distribution |
| M50 SC171 | In distribution | |
| M50 SU152 | Length 40.57 mm | In distribution |
| M50 SU213 | Length 29.49 mm | In distribution |
| M50 ST210 | Length 29.49 mm | In distribution |
| M50 SC173 | In distribution | |
| M50 ST241 | Length 40.51 mm | In distribution |
| M50 SU136 | Length 34.47 mm | In distribution |
| M50 ST130 | Length 34.47 mm | In distribution |
| M50 SU258 | Length 40.57 mm | In distribution |
| M50 SC271 | In distribution | |
| M50 SU261 | Length 43.51 mm | In distribution |
| M50 SC142 | Length 33.22 mm | In distribution |
| M50 SU259 | Length 40.57 mm | In distribution |
| M50 SU226 | Length 31.58 mm | In distribution |
| M50 SU156 | Length 40.57 mm | In distribution |
| M50 SU166 | Length 43.51 mm | In distribution |
| M50 SU233 | Length 34.47 mm | In distribution |
| M50 SC272 | In distribution | |
| M50 SU255 | Length 40.57 mm | In distribution |
| M50 SU211 | Length 29.49 mm | In distribution |
| M50 ST160 | Length 43.51 mm | In distribution |
| M50 SC144 | Length 38.91 mm | In distribution |
| M50 SU169 | Length 43.51 mm | In distribution |
| M50 ST161 | Length 46.51 mm | In distribution |
| M50 SU263 | Length 43.51 mm | In distribution |
| M50 SU262 | Length 43.51 mm | In distribution |
| M50 SU115 | Length 29.49 mm | In distribution |
| M50 SC133 | Length 36.12 mm | In distribution |
| M50 SC141 | Length 31.40 mm | In distribution |
| M05 PSI | In distribution | |
| M50 SU117 | Length 29.49 mm | In distribution |
| M50 SU222 | Length 31.58 mm | In distribution |
| M50 SU118 | Length 29.49 mm | In distribution |
| M50 SU227 | Length 31.58 mm | In distribution |
| M50 SU266 | Length 43.51 mm | In distribution |
| M50 ST140 | Length 37.51 mm | In distribution |
| M50 SU242 | Length 37.51 mm | In distribution |
| M50 SU217 | Length 29.49 mm | In distribution |
| M50 SC244 | Length 38.91 mm | In distribution |
| M50 SU155 | Length 40.57 mm | In distribution |
| M50 SC174 | In distribution | |
| M50 SU231 | Length 34.47 mm | In distribution |
| M50 SU245 | Length 37.51 mm | In distribution |
| M50 SU142 | Length 37.51 mm | In distribution |
| M50 SU127 | Length 31.58 mm | In distribution |
| M50 SU128 | Length 31.58 mm | In distribution |
| M50 ST131 | Length 37.47 mm | In distribution |
| M50 SU238 | Length 34.47 mm | In distribution |
| M50 SC175 | In distribution | |
| M50 SU168 | Length 43.51 mm | In distribution |
| M50 ST231 | Length 37.47 mm | In distribution |
| M50 SC243 | Length 36.12 mm | In distribution |
| M50 SU223 | Length 31.58 mm | In distribution |
| M50 ST120 | Length 31.58 mm | In distribution |
| M50 SU141 | Length 37.51 mm | In distribution |
| M50 SC136 | Length 44.51 mm | In distribution |
| M50 SU232 | Length 34.47 mm | In distribution |
| M50 ST121 | Length 34.58 mm | In distribution |
| M50 SC274 | In distribution | |
| M50 ST150 | Length 40.57 mm | In distribution |
| M50 SU123 | Length 31.58 mm | In distribution |
| M50 SU148 | Length 37.51 mm | In distribution |
| M50 SC232 | Length 33.27 mm | In distribution |
| M50 SU143 | Length 37.51 mm | In distribution |
| M50 SU229 | Length 31.58 mm | In distribution |
| M50 SU219 | Length 29.49 mm | In distribution |
| M50 SU113 | Length 29.49 mm | In distribution |
| M50 SU116 | Length 29.49 mm | In distribution |
| M50 SC231 | Length 31.38 mm | In distribution |
| M50 SU256 | Length 40.57 mm | In distribution |
| M50 SU251 | Length 40.57 mm | In distribution |
| M50 SU257 | Length 40.57 mm | In distribution |
| M50 SU246 | Length 37.51 mm | In distribution |
| M50 SU132 | Length 34.47 mm | In distribution |
| M50 SC134 | Length 38.93 mm | In distribution |
| M50 SU149 | Length 37.51 mm | In distribution |
| M50 SC273 | In distribution | |
| M50 SU162 | Length 43.51 mm | In distribution |
| M50 SC275 | In distribution | |
| M50 SU163 | Length 43.51 mm | In distribution |
| M50 ST110 | Length 29.49 mm | In distribution |
| M50 SU146 | Length 37.51 mm | In distribution |
| M50 ST230 | Length 34.47 mm | In distribution |
| M50 SU228 | Length 31.58 mm | In distribution |
| M50 SU216 | Length 29.49 mm | In distribution |
| M50 SU137 | Length 34.47 mm | In distribution |
| M50 SC245 | Length 41.64 mm | In distribution |
| M50 SC146 | Length 44.45 mm | In distribution |
| M50 SU145 | Length 37.51 mm | In distribution |
| M50 SC172 | In distribution | |
| M50 SU131 | Length 34.47 mm | In distribution |
| M50 SU151 | Length 40.57 mm | In distribution |
| M50 SC145 | Length 41.64 mm | In distribution |
| M50 SU167 | Length 43.51 mm | In distribution |
| M50 ST251 | Length 43.57 mm | In distribution |
| M50 SC233 | Length 36.12 mm | In distribution |
| M50 SU239 | Length 34.47 mm | In distribution |
| M50 SU269 | Length 43.51 mm | In distribution |
| M50 SC234 | Length 38.93 mm | In distribution |
| M50 SC131 | Length 31.38 mm | In distribution |
| M50 SU236 | Length 34.47 mm | In distribution |
| M50 SU235 | Length 34.47 mm | In distribution |
| M50 SU125 | Length 31.58 mm | In distribution |
| M50 SC143 | Length 36.12 mm | In distribution |
| M50 SC236 | Length 44.51 mm | In distribution |
| M50 SU161 | Length 43.51 mm | In distribution |
| M50 SU138 | Length 34.47 mm | In distribution |
| M50 SU247 | Length 37.51 mm | In distribution |
| M50 SC176 | In distribution | |
| M50 SU253 | In distribution | |
| M50 SU212 | Length 29.49 mm | In distribution |
| M50 ST221 | Length 34.58 mm | In distribution |
| M50 SU159 | Length 40.57 mm | In distribution |
| M50 ST211 | Length 32.49 mm | 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 |
| Hintermann Series H2 | Vilex LLC | 153 |
| Trabecular Metal® | Zimmer, Inc. | 145 |
Showing 12 of 53. All products under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231699 | 2024-04-23 |
| K230313 | 2023-04-06 |
| K211883 | 2021-08-11 |
| K191380 | 2020-01-29 |
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.