Apex 3d Total Ankle Replacement System
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 1 Narrow
1manufacturer
658catalogue numbers in this listing
7510(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 | 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) | K192994 |
| Record published | 2020-12-15 |
| Record revised | 2026-02-09 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P10-911-TB4R | In distribution | |
| P10-31A-I406-S | In distribution | |
| P10-921-TLR3 | In distribution | |
| P10-310-I314-S | In distribution | |
| P10-310-I518-S | In distribution | |
| P10-31A-I115-S | In distribution | |
| P10-31P-I515-S | In distribution | |
| P10-101-BL3L-S | In distribution | |
| P10-31A-I306-S | In distribution | |
| P10-101-BL2L-S | In distribution | |
| P10-920-TLR1 | In distribution | |
| P10-31P-I307-S | In distribution | |
| P10-31P-I312-S | In distribution | |
| P10-100-BL3L-S | In distribution | |
| P10-31P-I420-S | In distribution | |
| P10-201-TLR3-S | In distribution | |
| P10-100-BL10-S | In distribution | |
| P10-100-BL4L-S | In distribution | |
| P10-310-I510-S | In distribution | |
| P10-931-I106 | In distribution | |
| P10-101-BR4S-S | In distribution | |
| P10-930-I510 | In distribution | |
| P10-310-I520-S | In distribution | |
| P10-930-I214 | In distribution | |
| P10-930-I114 | In distribution | |
| P10-930-I406 | In distribution | |
| P10-31P-I209-S | In distribution | |
| P10-100-BR1S-S | In distribution | |
| P10-920-TLR3 | In distribution | |
| P10-31A-I507-S | In distribution | |
| P10-100-BL2S-S | In distribution | |
| P10-100-BR6L-S | In distribution | |
| P10-31A-I409-S | In distribution | |
| P10-31A-I508-S | In distribution | |
| P10-251-TLR1-S | In distribution | |
| P10-31A-I107-S | In distribution | |
| P10-31A-I510-S | In distribution | |
| P10-930-I108 | In distribution | |
| P10-310-I308-S | In distribution | |
| P10-200-TLL3-S | In distribution | |
| P10-931-I514 | In distribution | |
| P10-310-I211-S | In distribution | |
| P10-310-I510-S | In distribution | |
| P10-310-I310-S | In distribution | |
| P10-310-I108-S | In distribution | |
| P10-931-I110 | In distribution | |
| P10-100-BL6S-S | In distribution | |
| P10-930-I320 | In distribution | |
| P10-930-I507 | In distribution | |
| P10-100-BR4S-S | In distribution | |
| P10-930-I212 | In distribution | |
| P10-310-I408-S | In distribution | |
| P10-813-TB1U | In distribution | |
| P10-251-TLL5-S | In distribution | |
| P10-31P-I512-S | In distribution | |
| P10-812-TB4U | In distribution | |
| P10-31A-I413-S | In distribution | |
| P10-930-I107 | In distribution | |
| P10-310-I307-S | In distribution | |
| P10-930-I118 | In distribution | |
| P10-920-TLL4 | In distribution | |
| P10-100-BR4L-S | In distribution | |
| P10-31A-I420-S | In distribution | |
| P10-931-I515 | In distribution | |
| P10-31P-I111-S | In distribution | |
| P10-251-TLL4-S | In distribution | |
| P10-201-TLR4-S | In distribution | |
| P10-931-I219 | In distribution | |
| P10-250-TLR5-S | In distribution | |
| P10-100-BL5S-S | In distribution | |
| P10-931-I415 | In distribution | |
| P10-201-TLL5-S | In distribution | |
| P10-931-I507 | In distribution | |
| P10-31P-I109-S | In distribution | |
| P10-31P-I406-S | In distribution | |
| P10-310-I309-S | In distribution | |
| P10-310-I414-S | In distribution | |
| P10-31P-I215-S | In distribution | |
| P10-310-I220-S | In distribution | |
| P10-31A-I511-S | In distribution | |
| P10-851-TP56 | In distribution | |
| P10-101-BL5S-S | In distribution | |
| P10-31A-I308-S | In distribution | |
| P10-31A-I218-S | In distribution | |
| P10-200-TLR5-S | In distribution | |
| P10-100-BL3S-S | In distribution | |
| P10-930-I508 | In distribution | |
| P10-31P-I108-S | In distribution | |
| P10-310-I516-S | In distribution | |
| P10-31A-I116-S | In distribution | |
| P10-911-TB3L | In distribution | |
| P10-101-BL1L-S | In distribution | |
| P10-100-BR10-S | In distribution | |
| P10-931-I319 | In distribution | |
| P10-931-I419 | In distribution | |
| P10-251-TLL2-S | In distribution | |
| P10-310-I211-S | In distribution | |
| P10-31A-I216-S | In distribution | |
| P10-931-I420 | In distribution | |
| P10-310-I411-S | In distribution | |
| P10-31P-I408-S | In distribution | |
| P10-921-TLL0 | In distribution | |
| P10-310-I107-S | In distribution | |
| P10-310-I206-S | In distribution | |
| P10-101-BL10-S | In distribution | |
| P10-931-I509 | In distribution | |
| P10-100-BL5L-S | In distribution | |
| P10-910-TB4R | In distribution | |
| P10-101-BL10-S | In distribution | |
| P10-310-I410-S | In distribution | |
| P10-100-BR2S-S | In distribution | |
| P10-100-BL6L-S | In distribution | |
| P10-310-I114-S | In distribution | |
| P10-251-TLR2-S | In distribution | |
| P10-31A-I118-S | In distribution | |
| P10-910-TB2R | In distribution | |
| P10-310-I409-S | In distribution | |
| P10-31A-I512-S | In distribution | |
| P10-842-AC05 | In distribution | |
| P10-920-TFT0 | In distribution | |
| P10-813-TB3U | In distribution | |
| P10-101-BL3L-S | In distribution | |
| P10-310-I214-S | In distribution | |
| P10-31A-I120-S | In distribution | |
| P10-931-I310 | In distribution | |
| P10-812-TB5U | In distribution | |
| P10-31P-I110-S | In distribution | |
| P10-100-BL1S-S | In distribution | |
| P10-310-I210-S | In distribution | |
| P10-31P-I516-S | In distribution | |
| P10-921-TLR4 | In distribution | |
| P10-101-BL5L-S | In distribution | |
| P10-31P-I210-S | In distribution | |
| P10-310-I216-S | In distribution | |
| P10-931-I512 | In distribution | |
| P10-31P-I120-S | In distribution | |
| P10-910-TB4L | In distribution | |
| P10-310-I120-S | In distribution | |
| P10-930-I116 | In distribution | |
| P10-101-BR2L-S | In distribution | |
| P10-931-I517 | In distribution | |
| P10-101-BR1L-S | In distribution | |
| P10-310-I120-S | In distribution | |
| P10-931-I508 | In distribution | |
| P10-101-BL5S-S | In distribution | |
| P10-101-BR10-S | In distribution | |
| P10-911-TB4L | In distribution | |
| P10-101-BR6L-S | In distribution | |
| P10-931-I417 | In distribution | |
| P10-31P-I118-S | In distribution | |
| P10-31P-I216-S | In distribution | |
| P10-250-TLL2-S | In distribution | |
| P10-930-I407 | In distribution | |
| P10-100-BL3L-S | In distribution | |
| P10-200-TLL0-S | In distribution | |
| P10-101-BL6S-S | In distribution | |
| P10-931-I320 | In distribution | |
| P10-310-I420-S | In distribution | |
| P10-250-TLL5-S | In distribution | |
| P10-31A-I520-S | In distribution | |
| P10-100-BL2L-S | In distribution | |
| P10-101-BR6L-S | In distribution | |
| P10-31P-I218-S | In distribution | |
| P10-931-I208 | In distribution | |
| P10-310-I111-S | In distribution | |
| P10-251-TLL3-S | In distribution | |
| P10-310-I212-S | In distribution | |
| P10-31P-I315-S | In distribution | |
| P10-100-BR1S-S | In distribution | |
| P10-31A-I506-S | In distribution | |
| P10-921-TLL2 | In distribution | |
| P10-31A-I513-S | In distribution | |
| P10-250-TLL0-S | In distribution | |
| P10-920-TLL0 | In distribution | |
| P10-813-TB5U | In distribution | |
| P10-251-TLR3-S | In distribution | |
| P10-31A-I219-S | In distribution | |
| P10-31P-I219-S | In distribution | |
| P10-931-I318 | In distribution | |
| P10-100-BR5S-S | In distribution | |
| P10-100-BR5L-S | In distribution | |
| P10-931-I307 | In distribution | |
| P10-31A-I111-S | In distribution | |
| P10-101-BR3S-S | In distribution | |
| P10-310-I316-S | In distribution | |
| P10-310-I206-S | In distribution | |
| P10-310-I412-S | In distribution | |
| P10-31P-I211-S | In distribution | |
| P10-31P-I213-S | In distribution | |
| P10-31A-I410-S | In distribution | |
| P10-101-BL1S-S | In distribution | |
| P10-101-BL4L-S | In distribution | |
| P10-310-I314-S | In distribution | |
| P10-921-TLR5 | In distribution | |
| P10-250-TLL4-S | In distribution | |
| P10-201-TLL4-S | In distribution | |
| P10-931-I506 | In distribution | |
| P10-910-TB1L | In distribution | |
| P10-812-TB6U | In distribution | |
| P10-910-TB3L | In distribution | |
| P10-310-I106-S | In distribution | |
| P10-941-LAZM | In distribution | |
| P10-310-I512-S | In distribution | |
| P10-813-TB2U | In distribution | |
| P10-931-I217 | In distribution | |
| P10-101-BR3L-S | In distribution | |
| P10-251-TLR3-S | In distribution | |
| P10-310-I110-S | In distribution | |
| P10-930-I516 | In distribution | |
| P10-931-I211 | In distribution | |
| P10-250-TLL4-S | In distribution | |
| P10-101-BR2S-S | In distribution | |
| P10-930-I111 | In distribution | |
| P10-101-BR1L-S | In distribution | |
| P10-944-LL04 | In distribution | |
| P10-31P-I214-S | In distribution | |
| P10-310-I109-S | In distribution | |
| P10-251-TLL5-S | In distribution | |
| P10-251-TLR4-S | In distribution | |
| P10-310-I318-S | In distribution | |
| P10-250-TLL3-S | In distribution | |
| P10-930-I310 | In distribution | |
| P10-911-TB2L | In distribution | |
| P10-250-TLR3-S | In distribution | |
| P10-100-BR4S-S | In distribution | |
| P10-31P-I220-S | In distribution | |
| P10-101-BR6S-S | In distribution | |
| P10-812-TB3U | In distribution | |
| P10-930-I308 | In distribution | |
| P10-100-BR6S-S | In distribution | |
| P10-310-I411-S | In distribution | |
| P10-200-TLL5-S | In distribution | |
| P10-250-TLR0-S | In distribution | |
| P10-813-TB6U | In distribution | |
| P10-310-I118-S | In distribution | |
| P10-310-I514-S | In distribution | |
| P10-920-TLR0 | In distribution | |
| P10-100-BL4L-S | In distribution | |
| P10-31P-I508-S | In distribution | |
| P10-910-TB5R | In distribution | |
| P10-100-BR2L-S | In distribution | |
| P10-31A-I418-S | In distribution | |
| P10-250-TLR1-S | In distribution | |
| P10-31A-I411-S | In distribution | |
| P10-31P-I513-S | In distribution | |
| P10-930-I120 | In distribution | |
| P10-31P-I411-S | In distribution | |
| P10-930-I209 | In distribution | |
| P10-100-BR3S-S | In distribution | |
| P10-931-I220 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| 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.