Vantage
Special Vantage Sharp Reamer, Straight Blade, Cone Tip - 15mm Tall x 12mm Diameter
1manufacturer
362catalogue numbers in this listing
4510(k) clearances naming this product code
5recalls on this 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 | Exactech, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K230717 |
| Record published | 2024-08-28 |
| Record revised | 2022-06-10 (version 4) |
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, serial number |
| Sizes | Length 33 to 48 mm; width 25 to 38 mm; height 10 to 30 mm; outer diameter 8 to 15 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03-PML-20-0002 | Length 35 mm | In distribution |
| 351-00-23 | SIZE 3L | In distribution |
| 03-LNB-CB-0006 | Size 6 | In distribution |
| 351-00-06 | In distribution | |
| 03-PML-10-0003 | Length 38 mm | In distribution |
| 350-21-41 | Size 1 | In distribution |
| 351-02-03 | SIZE 3 | In distribution |
| 03-PNB-RM-2512 | Height 25 mm | In distribution |
| SPI-038190 | In distribution | |
| 03-PNB-CB-0006 | Size 6 | In distribution |
| 351-10-26 | In distribution | |
| 351-00-29 | SIZE 4R | In distribution |
| 03-CNB-RM-1508 | Outer Diameter 8 mm | In distribution |
| 03-PMR-15-0003 | Width 27 mm | In distribution |
| 03-LNL-PG-0003 | Left | In distribution |
| 350-11-02 | Size 2, left | In distribution |
| 350-22-05 | Size 5 | In distribution |
| 351-10-15 | In distribution | |
| 03-CNB-MP-0000 | In distribution | |
| 351-05-03 | SIZE 3 | In distribution |
| 350-22-44 | right | In distribution |
| 350-04-05 | Size 5, right | In distribution |
| 03-CNB-PP-0000 | In distribution | |
| 350-04-04 | Size 4, right | In distribution |
| 351-10-03 | SIZE 3-4 L | In distribution |
| 03-CNB-RM-1510 | Outer Diameter 10 mm | In distribution |
| 351-06-00 | In distribution | |
| 351-12-03 | SIZE 3 | In distribution |
| 03-PMR-10-0001 | 10MM Cage Height | In distribution |
| 350-01-02 | Size 2, left | In distribution |
| 03-PNB-AW-0102 | Size 1-2 | In distribution |
| 351-10-00 | In distribution | |
| SPI-038192 | In distribution | |
| 351-10-12 | In distribution | |
| 350-02-04 | Size 4, right | In distribution |
| 351-05-00 | In distribution | |
| 03-PNB-RM-2010 | Height 20 mm | In distribution |
| 350-04-02 | Size 2, right | In distribution |
| 03-LMR-10-0002 | Length 36 mm | In distribution |
| 351-02-01 | SIZE 1 | In distribution |
| 03-CNB-RM-1011 | Outer Diameter 11 mm | In distribution |
| 350-03-01 | Size 1, left | In distribution |
| 03-PML-10-0006 | Width 33 mm | In distribution |
| 350-21-51 | left | In distribution |
| 03-LNB-CB-0005 | Size 5 | In distribution |
| 03-PNB-FT-0003 | Size 3 | In distribution |
| 350-01-05 | Size 5, left | In distribution |
| 351-10-25 | In distribution | |
| 350-21-44 | left | In distribution |
| 351-10-17 | In distribution | |
| SPI-012546 | In distribution | |
| 350-11-03 | Size 3, left | In distribution |
| 351-00-24 | SIZE 4L | In distribution |
| 03-CNB-AW-0000 | In distribution | |
| 350-03-04 | Size 4, left | In distribution |
| 351-10-11 | In distribution | |
| 03-CNB-DR-0001 | In distribution | |
| 03-PNB-RM-2511 | Height 25 mm | In distribution |
| 350-22-31 | right | In distribution |
| 351-05-02 | SIZE 2 | In distribution |
| 350-21-32 | Size 2 | In distribution |
| 03-LNB-CB-0003 | Size 3 | In distribution |
| 03-PML-30-0004 | Width 29 mm | In distribution |
| 350-22-63 | Size 3 | In distribution |
| 351-10-16 | In distribution | |
| 03-PNB-MB-0003 | Size 3 | In distribution |
| 351-00-26 | SIZE 1R | In distribution |
| 351-00-13 | SIZE 3 | In distribution |
| 03-CNB-RM-1515 | Outer Diameter 15 mm | In distribution |
| 350-22-23 | right | In distribution |
| 351-11-04 | LEFT | In distribution |
| 03-PNB-RM-3013 | Outer Diameter 13 mm | In distribution |
| 03-LMR-10-0004 | 10MM Cage Height | In distribution |
| 351-07-04 | In distribution | |
| 03-LNB-CB-0002 | Size 2 | In distribution |
| 03-PML-15-0001 | 15MM Cage Height | In distribution |
| 03-LNL-PG-0004 | Left | In distribution |
| 03-PMR-20-0004 | Length 41 mm | In distribution |
| 03-LNR-PG-0001 | Size 1 | In distribution |
| 351-11-02 | SIZE 2 | In distribution |
| 03-PNB-MB-0004 | Size 4 | In distribution |
| 350-10-02 | Size 2 | In distribution |
| 350-01-04 | Size 4, left | In distribution |
| 03-PNB-RM-2510 | Height 25 mm | In distribution |
| 03-PNB-CB-0004 | Size 4 | In distribution |
| 03-CNB-RM-1509 | Outer Diameter 9 mm | In distribution |
| 351-00-11 | SIZE 1 | In distribution |
| 350-22-03 | Size 3 | In distribution |
| 350-04-01 | Size 1, right | In distribution |
| 350-22-13 | Size 3 | In distribution |
| 351-02-02 | SIZE 2 | In distribution |
| 350-21-42 | left | In distribution |
| 351-10-01 | SIZE 1-2 L | In distribution |
| 351-00-21 | SIZE 1L | In distribution |
| 350-22-64 | right | In distribution |
| 351-00-28 | SIZE 3R | In distribution |
| 03-PNB-CB-0003 | Size 3 | In distribution |
| 351-11-01 | LEFT | In distribution |
| SPI-008926 | In distribution | |
| 03-PML-25-0005 | Width 31 mm | In distribution |
| 350-21-02 | Size 2 | In distribution |
| 350-21-33 | Size 3 | In distribution |
| 351-00-27 | SIZE 2R | In distribution |
| 351-10-30 | In distribution | |
| 03-PNB-RM-2013 | Height 20 mm | In distribution |
| 03-PNB-RM-3012 | Height 30 mm | In distribution |
| 350-02-01 | Size 1, right | In distribution |
| 350-03-02 | Size 2, left | In distribution |
| 03-PMR-15-0002 | Size 2 | In distribution |
| 350-21-64 | left | In distribution |
| 350-21-12 | Size 2 | In distribution |
| 03-PNB-FT-0004 | Size 4 | In distribution |
| 03-PNB-RM-3011 | Outer Diameter 11 mm | In distribution |
| 03-PML-10-0005 | Left | In distribution |
| 351-10-33 | In distribution | |
| 03-PNB-PG-0005 | Size 5 | In distribution |
| 03-PML-25-0001 | Length 33 mm | In distribution |
| 350-22-02 | right | In distribution |
| 03-PMR-10-0005 | 10MM Cage Height | In distribution |
| 03-LML-10-0002 | 10MM Cage Height | In distribution |
| 03-PNB-MB-0001 | Size 1 | In distribution |
| 351-10-04 | SIZE 3-4 R | In distribution |
| 03-PML-30-0001 | 30MM Cage Height | In distribution |
| 03-PNB-PG-0006 | Size 6 | In distribution |
| 03-PMR-30-0004 | Length 41 mm | In distribution |
| 03-PNB-RM-2513 | Outer Diameter 13 mm | In distribution |
| 03-PML-25-0003 | 25MM Cage Height | In distribution |
| 03-CNB-RM-1010 | Height 10 mm | In distribution |
| 350-22-61 | Size 1 | In distribution |
| 351-00-25 | SIZE 5L | In distribution |
| 03-LNL-PG-0005 | Left | In distribution |
| 03-CNB-RM-1009 | Outer Diameter 9 mm | In distribution |
| 350-22-24 | Size 4 | In distribution |
| 351-10-13 | In distribution | |
| 03-CNB-RM-1013 | Outer Diameter 13 mm | In distribution |
| SPI-038238 | In distribution | |
| 03-PNB-RM-2014 | Outer Diameter 14 mm | In distribution |
| 350-21-25 | Size 5 | In distribution |
| 351-10-18 | In distribution | |
| SPI-006500 | In distribution | |
| 03-PML-15-0002 | 15MM Cage Height | In distribution |
| 351-05-01 | SIZE 1 | In distribution |
| 03-LNL-PG-0002 | Size 2 | In distribution |
| 03-PMR-20-0006 | Right | In distribution |
| 03-PNB-FT-0006 | Size 6 | In distribution |
| 351-00-02 | +2 Cut Height | In distribution |
| 03-PMR-15-0005 | Length 45 mm | In distribution |
| 03-PMR-30-0001 | Length 33 mm | In distribution |
| 351-01-10 | In distribution | |
| 350-10-03 | Size 3 | In distribution |
| 03-PNB-FT-0003 | Size 3 | In distribution |
| 350-21-53 | left | In distribution |
| 350-21-35 | Size 5 | In distribution |
| SPI-041941 | In distribution | |
| 03-CNB-RM-1008 | Outer Diameter 8 mm | In distribution |
| 03-LML-10-0003 | 10MM Cage Height | In distribution |
| 03-PNB-MB-0002 | Size 2 | In distribution |
| 03-PML-25-0002 | Left | In distribution |
| 03-PMR-30-0002 | Size 2 | In distribution |
| 03-LNB-CB-0004 | Size 4 | In distribution |
| 03-PNB-RM-2011 | Height 20 mm | In distribution |
| 03-PMR-30-0006 | Width 33 mm | In distribution |
| 03-LNR-PG-0003 | Size 3 | In distribution |
| 350-21-22 | left | In distribution |
| 351-11-03 | SIZE 3 | In distribution |
| 03-PMR-20-0003 | Width 27 mm | In distribution |
| 03-PNB-RM-3015 | Height 30 mm | In distribution |
| 03-PNB-FT-0005 | Size 5 | In distribution |
| 03-CMB-LC-0004 | Size 4 | In distribution |
| 350-22-54 | Size 4 | In distribution |
| 350-12-02 | Size 2, right | In distribution |
| 350-22-01 | Size 1 | In distribution |
| 350-22-42 | right | In distribution |
| SK-032634 | In distribution | |
| 351-07-03 | In distribution | |
| 351-90-02 | In distribution | |
| 03-LML-10-0001 | Left | In distribution |
| 03-CMB-LC-0006 | Size 6 | In distribution |
| 351-00-22 | SIZE 2L | In distribution |
| 350-03-03 | Size 3, left | In distribution |
| 03-LNB-CB-0001 | Size 1 | In distribution |
| 03-PML-10-0002 | Length 35 mm | In distribution |
| 350-02-05 | Size 5, right | In distribution |
| 351-07-00 | In distribution | |
| 03-PML-15-0004 | 15MM Cage Height | In distribution |
| 351-05-04 | SIZE 4 | In distribution |
| 03-PNB-RM-2515 | Height 25 mm | In distribution |
| 350-10-01 | Size 1 | In distribution |
| 03-PML-25-0004 | 25MM Cage Height | In distribution |
| 350-22-22 | Size 2 | In distribution |
| 350-22-35 | right | In distribution |
| 03-LMR-10-0006 | Size 6 | In distribution |
| 03-LMR-10-0001 | Length 34 mm | In distribution |
| 350-03-05 | Size 5, left | In distribution |
| 351-05-05 | SIZE 5 | In distribution |
| 03-PNB-FT-0004 | Size 4 | In distribution |
| 03-PNB-AW-0006 | Size 6 | In distribution |
| 350-21-54 | Size 4 | In distribution |
| 351-12-02 | SIZE 2 | In distribution |
| 03-PMR-20-0002 | Length 35 mm | In distribution |
| 351-10-02 | SIZE 1-2 R | In distribution |
| 350-21-23 | Size 3 | In distribution |
| 03-PMR-10-0002 | Width 25 mm | In distribution |
| 350-01-01 | Size 1, left | In distribution |
| 03-CNB-RM-1512 | Height 15 mm | In distribution |
| 03-PNB-FT-0006 | Size 6 | In distribution |
| 351-12-04 | RIGHT | In distribution |
| 350-22-32 | Size 2 | In distribution |
| 03-PMR-15-0006 | Width 33 mm | In distribution |
| 03-PMR-25-0005 | Right | In distribution |
| 350-21-65 | Size 5 | In distribution |
| 350-21-34 | left | In distribution |
| 03-PML-10-0001 | Left | In distribution |
| SPI-038413 | In distribution | |
| 03-CNB-AR-0000 | In distribution | |
| 03-CMB-LC-0102 | Size 1 & 2 | In distribution |
| 03-CNB-RM-1015 | Height 10 mm | In distribution |
| 350-22-45 | Size 5 | In distribution |
| 03-CNB-AP-0000 | In distribution | |
| 350-21-15 | left | In distribution |
| 351-00-12 | SIZE 2 | In distribution |
| 350-12-01 | Size 1, right | In distribution |
| 350-22-53 | right | In distribution |
| 350-02-02 | Size 2, right | In distribution |
| 03-PML-10-0004 | 10MM Cage Height | In distribution |
| 03-CNB-RM-1511 | Height 15 mm | In distribution |
| 03-LNB-CB-0006 | Size 6 | In distribution |
| 350-21-43 | Size 3 | In distribution |
| 03-PNB-RM-2514 | Height 25 mm | In distribution |
| 03-PNB-AW-0003 | Size 3 | In distribution |
| 03-PML-20-0001 | Length 33 mm | In distribution |
| 351-12-01 | SIZE 1 | In distribution |
| 350-21-63 | Size 3 | In distribution |
| 03-CNB-CC-0000 | In distribution | |
| SPI-012548 | In distribution | |
| 350-21-62 | left | In distribution |
| SPI-038414 | In distribution | |
| 03-PNB-PG-0004 | Size 4 | In distribution |
| 03-PMR-25-0004 | Width 29 mm | In distribution |
| 03-PNB-TP-0000 | In distribution | |
| 03-PNB-RM-3014 | Height 30 mm | In distribution |
| 350-21-52 | Size 2 | In distribution |
| 03-PNB-CB-0102 | Size 1-2 | In distribution |
| 350-22-25 | right | In distribution |
| 350-21-05 | left | In distribution |
| 350-21-04 | Size 4 | In distribution |
| 03-LNR-PG-0006 | Right | In distribution |
| 351-00-01 | +5 Cut Height | In distribution |
| 03-PML-30-0002 | Size 2 | In distribution |
| 350-22-62 | right | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apex 3D Total Ankle Replacement System | Paragon 28 | 658 |
| 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 |
|---|---|
| K230717 | 2023-10-12 |
| K232002 | 2023-09-11 |
| K183343 | 2019-04-01 |
| K152217 | 2016-03-10 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| Exactech, Inc. | 510(k) number | 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 2,217 devices | |
| Exactech, Inc. | 510(k) number | 2020-08-10 | Class II | Error in labeling | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a | 11 units | |
| Exactech, Inc. | 510(k) number | 2017-05-16 | Class II | Under Investigation by firm | Possible inner labeling and packaged device not matching the outer label on the box. | 9 | 2021-04-22 |
| Exactech, Inc. | 510(k) number | 2017-05-16 | Class II | Under Investigation by firm | Possible inner labeling and packaged device not matching the outer label on the box. | 9 | 2021-04-22 |
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.