Maestro Total Wrist
136 catalogue numbers from 180107, listed by Biomet Orthopedics, United States, under Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained. 1 manufacturer in China is registered for this product code.
1manufacturer
136catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JWJ |
| Device type | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3800 |
| 510(k) | K042032 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-14 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 180107 | 9 MM 43 MM | In distribution |
| 180122 | 6MM Ø 18MM LONG | In distribution |
| 180437 | Size 3 20mm Height | In distribution |
| 180153 | 9 mm | In distribution |
| 180104 | 9 MM 37 MM | In distribution |
| 180342 | 4.75MM Ø 25MM LENGTH | In distribution |
| 180095 | 9 mm 37 mm | In distribution |
| 180427 | Size 2 20mm Height | In distribution |
| 180427 | SIZE 2 20MM HEIGHT | In distribution |
| 180063 | STANDARD HEIGHT | In distribution |
| 180065 | +4mm Height | In distribution |
| 180180 | 4.5MM Ø 40MM LONG | In distribution |
| 180106 | 9 MM 43 MM | In distribution |
| 180464 | +2MM HEIGHT | In distribution |
| 180306 | 9 mm 43 mm | In distribution |
| 180151 | 7.5 mm | In distribution |
| 180437 | SIZE 3 20MM HEIGHT | In distribution |
| 180122 | 6mm Ø 18mm Long | In distribution |
| 180422 | SIZE 2 12MM HEIGHT | In distribution |
| 180432 | SIZE 3 12MM HEIGHT | In distribution |
| 180341 | 4.75mm Ø 20mm Length | In distribution |
| 180346 | 4.75MM Ø 45MM LENGTH | In distribution |
| 180423 | Size 2 12mm Height | In distribution |
| 180182 | 7.5mm Ø 40mm Long | In distribution |
| 180180 | 4.5mm Ø 40mm Long | In distribution |
| 180426 | SIZE 2 20MM HEIGHT | In distribution |
| 180303 | 9 MM 37 MM | In distribution |
| 180395 | 9 mm 37 mm | In distribution |
| 180322 | 6MM Ø 18MM LONG | In distribution |
| 180411 | SIZE 1 8MM HEIGHT | In distribution |
| 180483 | 9mm Ø 60mm Long | In distribution |
| 180182 | 7.5MM Ø 40MM LONG | In distribution |
| 180363 | Standard Height | In distribution |
| 180152 | 9 MM | In distribution |
| 180416 | SIZE 1 20MM HEIGHT | In distribution |
| 180320 | 6MM Ø 12MM LONG | In distribution |
| 180463 | Standard Height | In distribution |
| 180121 | 6MM Ø 15MM LONG | In distribution |
| 180480 | 4.5mm Ø 60mm Long | In distribution |
| 180414 | SIZE 1 16MM HEIGHT | In distribution |
| 180308 | 9 MM 43 MM | In distribution |
| 180321 | 6mm Ø 15mm Long | In distribution |
| 180416 | Size 1 20mm Height | In distribution |
| 180425 | SIZE 2 16MM HEIGHT | In distribution |
| 180410 | Size 1 8mm Height | In distribution |
| 180108 | 9 MM 43 MM | In distribution |
| 180103 | 9 MM 37 MM | In distribution |
| 180415 | Size 1 16mm Height | In distribution |
| 180181 | 6MM Ø 40MM LONG | In distribution |
| 180181 | 6mm Ø 40mm Long | In distribution |
| 180435 | Size 3 16mm Height | In distribution |
| 180410 | SIZE 1 8MM HEIGHT | In distribution |
| 180434 | Size 3 16mm Height | In distribution |
| 180308 | 9 mm 43 mm | In distribution |
| 180340 | 4.75mm Ø 15mm Length | In distribution |
| 180120 | 6MM Ø 12MM LONG | In distribution |
| 180105 | 9 MM 37 MM | In distribution |
| 180152 | 9 mm | In distribution |
| 180424 | SIZE 2 16MM HEIGHT | In distribution |
| 180307 | 9 MM 43 MM | In distribution |
| 180151 | 7.5 MM | In distribution |
| 180351 | 4.75mm Ø 20mm Length | In distribution |
| 180064 | +2MM HEIGHT | In distribution |
| 180321 | 6MM Ø 15MM LONG | In distribution |
| 180420 | SIZE 2 8MM HEIGHT | In distribution |
| 180150 | 7.5 mm | In distribution |
| 180424 | Size 2 16mm Height | In distribution |
| 180434 | SIZE 3 16MM HEIGHT | In distribution |
| 180481 | 6mm Ø 60mm Long | In distribution |
| 180103 | 9 mm 37 mm | In distribution |
| 180344 | 4.75MM Ø 35MM LENGTH | In distribution |
| 180344 | 4.75mm Ø 35mm Length | In distribution |
| 180363 | STANDARD HEIGHT | In distribution |
| 180064 | +2mm Height | In distribution |
| 180413 | SIZE 1 12MM HEIGHT | In distribution |
| 180121 | 6mm Ø 15mm Long | In distribution |
| 180095 | 9 MM 37 MM | In distribution |
| 180105 | 9 mm 37 mm | In distribution |
| 180320 | 6mm Ø 12mm Long | In distribution |
| 180183 | 9MM Ø 40MM LONG | In distribution |
| 180480 | 4.5MM Ø 60MM LONG | In distribution |
| 180422 | Size 2 12mm Height | In distribution |
| 180351 | 4.75MM Ø 20MM LENGTH | In distribution |
| 180304 | 9 mm 37 mm | In distribution |
| 180411 | Size 1 8mm Height | In distribution |
| 180425 | Size 2 16mm Height | In distribution |
| 180396 | 9 MM 43 MM | In distribution |
| 180306 | 9 MM 43 MM | In distribution |
| 180153 | 9 MM | In distribution |
| 180096 | 9 mm 43 mm | In distribution |
| 180065 | +4MM HEIGHT | In distribution |
| 180432 | Size 3 12mm Height | In distribution |
| 180063 | Standard Height | In distribution |
| 180104 | 9 mm 37 mm | In distribution |
| 180343 | 4.75MM Ø 30MM LENGTH | In distribution |
| 180417 | Size 1 20mm Height | In distribution |
| 180433 | SIZE 3 12MM HEIGHT | In distribution |
| 180420 | Size 2 8mm Height | In distribution |
| 180414 | Size 1 16mm Height | In distribution |
| 180412 | SIZE 1 12MM HEIGHT | In distribution |
| 180481 | 6MM Ø 60MM LONG | In distribution |
| 180120 | 6mm Ø 12mm Long | In distribution |
| 180482 | 7.5mm Ø 60mm Long | In distribution |
| 180096 | 9 MM 43 MM | In distribution |
| 180307 | 9 mm 43 mm | In distribution |
| 180423 | SIZE 2 12MM HEIGHT | In distribution |
| 180150 | 7.5 MM | In distribution |
| 180464 | +2mm Height | In distribution |
| 180357 | 4.75MM Ø 50MM LENGTH | In distribution |
| 180465 | +4MM HEIGHT | In distribution |
| 180463 | STANDARD HEIGHT | In distribution |
| 180396 | 9 mm 43 mm | In distribution |
| 180345 | 4.75MM Ø 40MM LENGTH | In distribution |
| 180436 | SIZE 3 20MM HEIGHT | In distribution |
| 180357 | 4.75mm Ø 50mm Length | In distribution |
| 180303 | 9 mm 37 mm | In distribution |
| 180305 | 9 mm 37 mm | In distribution |
| 180304 | 9 MM 37 MM | In distribution |
| 180483 | 9MM Ø 60MM LONG | In distribution |
| 180433 | Size 3 12mm Height | In distribution |
| 180417 | SIZE 1 20MM HEIGHT | In distribution |
| 180183 | 9mm Ø 40mm Long | In distribution |
| 180305 | 9 MM 37 MM | In distribution |
| 180436 | Size 3 20mm Height | In distribution |
| 180106 | 9 mm 43 mm | In distribution |
| 180465 | +4mm Height | In distribution |
| 180322 | 6mm Ø 18mm Long | In distribution |
| 180412 | Size 1 12mm Height | In distribution |
| 180435 | SIZE 3 16MM HEIGHT | In distribution |
| 180482 | 7.5MM Ø 60MM LONG | In distribution |
| 180395 | 9 MM 37 MM | In distribution |
| 180108 | 9 mm 43 mm | In distribution |
| 180415 | SIZE 1 16MM HEIGHT | In distribution |
| 180107 | 9 mm 43 mm | In distribution |
| 180413 | Size 1 12mm Height | In distribution |
| 180426 | Size 2 20mm Height | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Freedom Wrist Arthroplasty System | Smith & Nephew, Inc. | 70 |
| Integra® Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | 70 |
| Remotion | Stryker GmbH | 53 |
| Universal 2™ Total Wrist System | Ascension Orthopedics, Inc. | 43 |
| Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 34 |
| KinematX | Extremity Medical, LLC | 14 |
| Integra® | Ascension Orthopedics, Inc. | 1 |
| Precise | Stryker GmbH | 1 |
Recalls Naming This Product
15 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2017-02-17 | Class II | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | 28,253 in total | 2018-01-29 |
| Biomet, Inc. | 510(k) number | 2016-12-20 | Class I | Device Design | Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing. | 4388 | 2017-08-29 |
| Biomet, Inc. | 510(k) number | 2013-05-15 | Class II | Device Design | Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that | 17 | 2014-06-09 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1,575 units all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1,575 units all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 units all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products. | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1,575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2010-09-13 | Not classified | Pending | The firm received complaints regarding fracturing of the device. | 45 both products | 2011-07-27 |
| Biomet, Inc. | 510(k) number | 2010-09-13 | Not classified | Pending | The firm received complaints regarding fracturing of the device. | 45 both products | 2011-07-27 |
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.