Cadence™
The Cadence™ Talar Dome components are made out of Cobalt Chrome alloy (CoCr) with a porous titanium coating (Ti) and is secured to patient anatomy via bone cement. In conjunction with the…
The Cadence™ Talar Dome components are made out of Cobalt Chrome alloy (CoCr) with a porous titanium coating (Ti) and is secured to patient anatomy via bone cement. In conjunction with the Tibial Tray and an Insert, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
1manufacturer
248catalogue numbers in this listing
2510(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 | Ascension Orthopedics, Inc., 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 | Manufacturer |
| 510(k) | K151459 |
| Record published | 2016-01-12 |
| Record revised | 2023-01-25 (version 4) |
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 |
| Storage | Special storage condition: Store in a clean, dry environment. Protect from sunlight and extreme temperatures. |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10209158 | Size 1, Left, 8mm, Posterior Biased | In distribution |
| 10208214 | In distribution | |
| 10209149 | Size 1, Right, 9mm, Posterior Biased | In distribution |
| 10209521 | Size 5, Left, 11mm, Neutral | In distribution |
| 10209108 | Size 1, Right, 8mm, Neutral | In distribution |
| 10208205 | Size 5, L; 38mm L x 39.5mm W | In distribution |
| 10209446 | Size 4, Right, 6mm, Posterior Biased | In distribution |
| 10209139 | Size 1 Left 9mm Anterior-Biased | In distribution |
| 10209127 | Size 1 Right 7mm Anterior-Biased | In distribution |
| 10207212 | Size 2X, L; 40mm L x 34mm W | In distribution |
| 10209541 | Size 5 Left 11mm Anterior-Biased | In distribution |
| 10209318 | Size 3, Left, 8mm, Neutral | In distribution |
| 10207213 | Size 3X, L; 43mm L x 37mm W | In distribution |
| 10209512 | Size 5, Right, 12mm, Neutral | In distribution |
| 10208211 | In distribution | |
| 10209242 | Size 2 Left 12mm Anterior-Biased | In distribution |
| 10209150 | Size 1, Right, 10mm, Posterior Biased | In distribution |
| 10209560 | Size 5, Left, 10mm, Posterior Biased | In distribution |
| 10209441 | Size 4 Left 11mm Anterior-Biased | In distribution |
| 10209147 | Size 1, Right, 7mm, Posterior Biased | In distribution |
| 10207111 | Size 1X, R; 37mm L x 32.5mm W | In distribution |
| 10209159 | Size 1, Left, 9mm, Posterior Biased | In distribution |
| 10209556 | Size 5, Left, 6mm, Posterior Biased | In distribution |
| 10209210 | Size 2, Right, 10mm, Neutral | In distribution |
| 10208101 | Size 1, R; 31mm L x 30.5mm W | In distribution |
| 10209450 | Size 4, Right, 10mm, Posterior Biased | In distribution |
| 10209518 | Size 5, Left, 8mm, Neutral | In distribution |
| 10208111 | In distribution | |
| 10208113 | In distribution | |
| 10209430 | Size 4 Right 10mm Anterior-Biased | In distribution |
| 10209338 | Size 3 Left 8mm Anterior-Biased | In distribution |
| 10207201 | Size 1, L; 34mm L x 32.5mm W | In distribution |
| 10208203 | Size 3, L; 34mm L x 34mm W | In distribution |
| 10209246 | Size 2, Right, 6mm, Posterior Biased | In distribution |
| 10209239 | Size 2 Left 9mm Anterior-Biased | In distribution |
| 10209119 | Size 1, Left, 9mm, Neutral | In distribution |
| 10209342 | Size 3 Left 12mm Anterior-Biased | In distribution |
| 10209320 | Size 3, Left, 10mm, Neutral | In distribution |
| 10209220 | Size 2, Left, 10mm, Neutral | In distribution |
| 10208104 | Size 4, R; 36mm L x 37mm W | In distribution |
| 10209526 | Size 5 Right 6mm Anterior-Biased | In distribution |
| 10209557 | Size 5, Left, 7mm, Posterior Biased | In distribution |
| 10209539 | Size 5 Left 9mm Anterior-Biased | In distribution |
| 10209322 | Size 3, Left, 12mm, Neutral | In distribution |
| 10209406 | Size 4, Right, 6mm, Neutral | In distribution |
| 10209309 | Size 3, Right, 9mm, Neutral | In distribution |
| 10207104 | Size 4, R; 43mm L x 40mm W | In distribution |
| 10209316 | Size 3, Left, 6mm, Neutral | In distribution |
| 10209549 | Size 5, Right, 9mm, Posterior Biased | In distribution |
| 10209532 | Size 5 Right 12mm Anterior-Biased | In distribution |
| 10209240 | Size 2 Left 10mm Anterior-Biased | In distribution |
| 10209208 | Size 2, Right, 8mm, Neutral | In distribution |
| 10209156 | Size 1, Left, 6mm, Posterior Biased | In distribution |
| 10208204 | Size 4, L; 36mm L x 37mm W | In distribution |
| 10209216 | Size 2, Left, 6mm, Neutral | In distribution |
| 10209412 | Size 4, Right, 12mm, Neutral | In distribution |
| 10209340 | Size 3 Left 10mm Anterior-Biased | In distribution |
| 10209107 | Size 1, Right, 7mm, Neutral | In distribution |
| 10209427 | Size 4 Right 7mm Anterior-Biased | In distribution |
| 10209151 | Size 1, Right, 11mm, Posterior Biased | In distribution |
| 10209259 | Size 2, Left, 9mm, Posterior Biased | In distribution |
| 10209420 | Size 4, Left, 10mm, Neutral | In distribution |
| 10207101 | Size 1; 34.5mm L x 32.5mm W | In distribution |
| 10209142 | Size 1 Left 12mm Anterior-Biased | In distribution |
| 10209221 | Size 2, Left, 11mm, Neutral | In distribution |
| 10209229 | Size 2 Right 9mm Anterior-Biased | In distribution |
| 10207214 | Size 4X, L; 46mm L x 40mm W | In distribution |
| 10209251 | Size 2, Right, 11mm, Posterior Biased | In distribution |
| 10209321 | Size 3, Left, 11mm, Neutral | In distribution |
| 10209426 | Size 4 Right 6mm Anterior-Biased | In distribution |
| 10209527 | Size 5 Right 7mm Anterior-Biased | In distribution |
| 10209436 | Size 4 Left 6mm Anterior-Biased | In distribution |
| 10209558 | Size 5, Left, 8mm, Posterior Biased | In distribution |
| 10209460 | Size 4, Left, 10mm, Posterior Biased | In distribution |
| 10209148 | Size 1, Right, 8mm, Posterior Biased | In distribution |
| 10209548 | Size 5, Right, 8mm, Posterior Biased | In distribution |
| 10209431 | Size 4 Right 11mm Anterior-Biased | In distribution |
| 10209348 | Size 3, Right, 8mm, Posterior Biased | In distribution |
| 10209442 | Size 4 Left 12mm Anterior-Biased | In distribution |
| 10209112 | Size 1, Right, 12mm, Neutral | In distribution |
| 10208212 | In distribution | |
| 10209462 | Size 4, Left, 12mm, Posterior Biased | In distribution |
| 10209157 | Size 1, Left, 7mm, Posterior Biased | In distribution |
| 10209536 | Size 5 Left 6mm Anterior-Biased | In distribution |
| 10209552 | Size 5, Right, 12mm, Posterior Biased | In distribution |
| 10208103 | Size 3, R; 34mm L x 34mm W | In distribution |
| 10209531 | Size 5 Right 11mm Anterior-Biased | In distribution |
| 10209452 | Size 4, Right, 12mm, Posterior Biased | In distribution |
| 10209359 | Size 3, Left, 9mm, Posterior Biased | In distribution |
| 10209129 | Size 1 Right 9mm Anterior-Biased | In distribution |
| 10209146 | Size 1, Right, 6mm, Posterior Biased | In distribution |
| 10209118 | Size 1, Left, 8mm, Neutral | In distribution |
| 10209128 | Size 1 Right 8mm Anterior-Biased | In distribution |
| 10209258 | Size 2, Left, 8mm, Posterior Biased | In distribution |
| 10209529 | Size 5 Right 9mm Anterior-Biased | In distribution |
| 10209508 | Size 5, Right, 8mm, Neutral | In distribution |
| 10209449 | Size 4, Right, 9mm, Posterior Biased | In distribution |
| 10209256 | Size 2, Left, 6mm, Posterior Biased | In distribution |
| 10209261 | Size 2, Left, 11mm, Posterior Biased | In distribution |
| 10209337 | Size 3 Left 7mm Anterior-Biased | In distribution |
| 10209540 | Size 5 Left 10mm Anterior-Biased | In distribution |
| 10209249 | Size 2, Right, 9mm, Posterior Biased | In distribution |
| 10209559 | Size 5, Left, 9mm, Posterior Biased | In distribution |
| 10209538 | Size 5 Left 8mm Anterior-Biased | In distribution |
| 10208102 | Size 2, R; 32.5mm L x 31mm W | In distribution |
| 10209422 | Size 4, Left, 12mm, Neutral | In distribution |
| 10209550 | Size 5, Right, 10mm, Posterior Biased | In distribution |
| 10209416 | Size 4, Left, 6mm, Neutral | In distribution |
| 10209428 | Size 4 Right 8mm Anterior-Biased | In distribution |
| 10209349 | Size 3, Right, 9mm, Posterior Biased | In distribution |
| 10209257 | Size 2, Left, 7mm, Posterior Biased | In distribution |
| 10209336 | Size 3 Left 6mm Anterior-Biased | In distribution |
| 10209121 | Size 1, Left, 11mm, Neutral | In distribution |
| 10209326 | Size 3 Right 6mm Anterior-Biased | In distribution |
| 10209132 | Size 1 Right 12mm Anterior-Biased | In distribution |
| 10209421 | Size 4, Left, 11mm, Neutral | In distribution |
| 10209438 | Size 4 Left 8mm Anterior-Biased | In distribution |
| 10209547 | Size 5, Right, 7mm, Posterior Biased | In distribution |
| 10209542 | Size 5 Left 12mm Anterior-Biased | In distribution |
| 10209161 | Size 1, Left, 11mm, Posterior Biased | In distribution |
| 10209237 | Size 2 Left 7mm Anterior-Biased | In distribution |
| 10209250 | Size 2, Right, 10mm, Posterior Biased | In distribution |
| 10209457 | Size 4, Left, 7mm, Posterior Biased | In distribution |
| 10209152 | Size 1, Right, 12mm, Posterior Biased Insert, Size 1, Right, 12mm, Posterior Biased | In distribution |
| 10209357 | Size 3, Left, 7mm, Posterior Biased | In distribution |
| 10209509 | Size 5, Right, 9mm, Neutral | In distribution |
| 10209116 | Size 1, Left, 6mm, Neutral | In distribution |
| 10208201 | Size 1, L; 31mm L x 30.5mm W | In distribution |
| 10209528 | Size 5 Right 8mm Anterior-Biased | In distribution |
| 10207204 | Size 4, L; 43mm L x 40mm W | In distribution |
| 10209520 | Size 5, Left, 10mm, Neutral | In distribution |
| 10209248 | Size 2, Right, 8mm, Posterior Biased | In distribution |
| 10209317 | Size 3, Left, 7mm, Neutral | In distribution |
| 10209459 | Size 4, Left, 9mm, Posterior Biased | In distribution |
| 10207102 | Size 2, R; 37mm L x 34mm W | In distribution |
| 10209356 | Size 3, Left, 6mm, Posterior Biased | In distribution |
| 10209140 | Size 1 Left 10mm Anterior-Biased | In distribution |
| 10209439 | Size 4 Left 9mm Anterior-Biased | In distribution |
| 10209409 | Size 4, Right, 9mm, Neutral | In distribution |
| 10209507 | Size 5, Right, 7mm, Neutral | In distribution |
| 10209137 | Size 1 Left 7mm Anterior-Biased | In distribution |
| 10207114 | Size 4X, R; 46mm L x 40mm W | In distribution |
| 10209546 | Size 5, Right, 6mm, Posterior Biased | In distribution |
| 10209130 | Size 1 Right 10mm Anterior-Biased | In distribution |
| 10207211 | Size 1X, L; 37mm L x 32.5mm W | In distribution |
| 10208105 | Size 5, R; 38mm L x 39.5mm W | In distribution |
| 10209111 | Size 1, Right, 11mm, Neutral | In distribution |
| 10209219 | Size 2, Left, 9mm, Neutral | In distribution |
| 10209227 | Size 2 Right 7mm Anterior-Biased | In distribution |
| 10209351 | Size 3, Right, 11mm, Posterior Biased | In distribution |
| 10208213 | In distribution | |
| 10209410 | Size 4, Right, 10mm, Neutral | In distribution |
| 10209519 | Size 5, Left, 9mm, Neutral | In distribution |
| 10209339 | Size 3 Left 9mm Anterior-Biased | In distribution |
| 10209232 | Size 2 Right 12mm Anterior-Biased | In distribution |
| 10209218 | Size 2, Left, 8mm, Neutral | In distribution |
| 10209306 | Size 3, Right, 6mm, Neutral | In distribution |
| 10209347 | Size 3, Right, 7mm, Posterior Biased | In distribution |
| 10209458 | Size 4, Left, 8mm, Posterior Biased | In distribution |
| 10207205 | Size 5, L; 46mm L x 44.5mm W | In distribution |
| 10209437 | Size 4 Left 7mm Anterior-Biased | In distribution |
| 10209122 | Size 1, Left, 12mm, Neutral | In distribution |
| 10209447 | Size 4, Right, 7mm, Posterior Biased | In distribution |
| 10209561 | Size 5, Left, 11mm, Posterior Biased | In distribution |
| 10209126 | Size 1 Right 6mm Anterior-Biased | In distribution |
| 10209419 | Size 4, Left, 9mm, Neutral | In distribution |
| 10208202 | Size 2, L; 32.5mm L x 31mm W | In distribution |
| 10209562 | Size 5, Left, 12mm, Posterior Biased | In distribution |
| 10209417 | Size 4, Left, 7mm, Neutral | In distribution |
| 10209252 | Size 2, Right, 12mm, Posterior Biased | In distribution |
| 10209418 | Size 4, Left, 8mm, Neutral | In distribution |
| 10209432 | Size 4 Right 12mm Anterior-Biased | In distribution |
| 10209360 | Size 3, Left, 10mm, Posterior Biased | In distribution |
| 10209262 | Size 2, Left, 12mm, Posterior Biased | In distribution |
| 10209346 | Size 3, Right, 6mm, Posterior Biased | In distribution |
| 10209236 | Size 2 Left 6mm Anterior-Biased | In distribution |
| 10209307 | Size 3, Right, 7mm, Neutral | In distribution |
| 10209429 | Size 4 Right 9mm Anterior-Biased | In distribution |
| 10207113 | Size 3X, R; 43mm L x 37mm W | In distribution |
| 10209247 | Size 2, Right, 7mm, Posterior Biased | In distribution |
| 10209407 | Size 4, Right, 7mm, Neutral | In distribution |
| 10209350 | Size 3, Right, 10mm, Posterior Biased | In distribution |
| 10209440 | Size 4 Left 10mm Anterior-Biased | In distribution |
| 10209106 | Size 1, Right, 6mm, Neutral | In distribution |
| 10209162 | Size 1, Left, 12mm, Posterior Biased | In distribution |
| 10209310 | Size 3, Right, 10mm, Neutral | In distribution |
| 10209510 | Size 5, Right, 10mm, Neutral | In distribution |
| 10209327 | Size 3 Right 7mm Anterior-Biased | In distribution |
| 10209511 | Size 5, Right, 11mm, Neutral | In distribution |
| 10209117 | Size 1, Left, 7mm, Neutral | In distribution |
| 10208114 | In distribution | |
| 10209109 | Size 1, Right, 9mm, Neutral | In distribution |
| 10209110 | Size 1, Right, 10mm, Neutral | In distribution |
| 10209231 | Size 2 Right 11mm Anterior-Biased | In distribution |
| 10209241 | Size 2 Left 11mm Anterior-Biased | In distribution |
| 10209461 | Size 4, Left, 11mm, Posterior Biased | In distribution |
| 10209209 | Size 2, Right, 9mm, Neutral | In distribution |
| 10209226 | Size 2 Right 6mm Anterior-Biased | In distribution |
| 10209530 | Size 5 Right 10mm Anterior-Biased | In distribution |
| 10209506 | Size 5, Right, 6mm, Neutral | In distribution |
| 10207105 | Size 5, R; 46mm L x 44.5mm W | In distribution |
| 10209411 | Size 4, Right, 11mm, Neutral | In distribution |
| 10209141 | Size 1 Left 11mm Anterior-Biased | In distribution |
| 10209451 | Size 4, Right, 11mm, Posterior Biased | In distribution |
| 10209537 | Size 5 Left 7mm Anterior-Biased | In distribution |
| 10209136 | Size 1 Left 6mm Anterior-Biased | In distribution |
| 10209160 | Size 1, Left, 10mm, Posterior Biased | In distribution |
| 10209207 | Size 2, Right, 7mm, Neutral | In distribution |
| 10209222 | Size 2, Left, 12mm, Neutral | In distribution |
| 10209330 | Size 3 Right 10mm Anterior-Biased | In distribution |
| 10209312 | Size 3, Right, 12mm, Neutral | In distribution |
| 10209408 | Size 4, Right, 8mm, Neutral | In distribution |
| 10209311 | Size 3, Right, 11mm, Neutral | In distribution |
| 10208112 | In distribution | |
| 10209238 | Size 2 Left 8mm Anterior-Biased | In distribution |
| 10209352 | Size 3, Right, 12mm, Posterior Biased | In distribution |
| 10209341 | Size 3 Left 11mm Anterior-Biased | In distribution |
| 10209516 | Size 5, Left, 6mm, Neutral | In distribution |
| 10209228 | Size 2 Right 8mm Anterior-Biased | In distribution |
| 10209329 | Size 3 Right 9mm Anterior-Biased | In distribution |
| 10209358 | Size 3, Left, 8mm, Posterior Biased | In distribution |
| 10209551 | Size 5, Right, 11mm, Posterior Biased | In distribution |
| 10207202 | Size 2, L; 37mm L x 34mm W | In distribution |
| 10209206 | Size 2, Right, 6mm, Neutral | In distribution |
| 10209131 | Size 1 Right 11mm Anterior-Biased | In distribution |
| 10207112 | Size 2X, R; 40mm L x 34mm W | In distribution |
| 10209212 | Size 2, Right, 12mm, Neutral | In distribution |
| 10209328 | Size 3 Right 8mm Anterior-Biased | In distribution |
| 10209260 | Size 2, Left, 10mm, Posterior Biased | In distribution |
| 10209120 | Size 1, Left, 10mm, Neutral | In distribution |
| 10209332 | Size 3 Right 12mm Anterior-Biased | In distribution |
| 10209331 | Size 3 Right 11mm Anterior-Biased | In distribution |
| 10209456 | Size 4, Left, 6mm, Posterior Biased | In distribution |
| 10209308 | Size 3, Right, 8mm, Neutral | In distribution |
| 10209138 | Size 1 Left 8mm Anterior-Biased | In distribution |
| 10207203 | Size 3, L; 40mm L x 37mm W | In distribution |
| 10209230 | Size 2 Right 10mm Anterior-Biased | In distribution |
| 10209211 | Size 2, Right, 11mm, Neutral | In distribution |
| 10209361 | Size 3, Left, 11mm, Posterior Biased | In distribution |
| 10209217 | Size 2, Left, 7mm, Neutral | In distribution |
| 10209362 | Size 3, Left, 12mm, Posterior Biased | In distribution |
| 10209319 | Size 3, Left, 9mm, Neutral | In distribution |
| 10209522 | Size 5, Left, 12mm, Neutral | In distribution |
| 10209517 | Size 5, Left, 7mm, Neutral | In distribution |
| 10209448 | Size 4, Right, 8mm, Posterior Biased | In distribution |
| 10207103 | Size 3, R; 40mm L x 37mm W | In distribution |
| 10208215 | Withdrawn | |
| 10208115 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apex 3D Total Ankle Replacement System | Paragon 28 | 658 |
| Vantage | Exactech, Inc. | 362 |
| 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 |
| 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 |
|---|---|
| K182878 | 2018-12-18 |
| K151459 | 2015-08-31 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2017-01-20 | Class II | Use error | Posterior tibial fractures have been reported. | 944 units | 2017-03-30 |
| Integra Lifesciences Corporation | 510(k) number | 2016-04-29 | Class II | Labeling mix-ups | As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly. The labeling incorrectly reflec | 12 units | 2016-10-19 |
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.