Comprehensive® Shoulder System
70 catalogue numbers from 113659, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
70catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MBF |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3670 |
| 510(k) | K060692 |
| Record published | 2019-08-30 |
| Record revised | 2025-10-30 (version 9) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 113659 | 19 mm 122mm Long | In distribution |
| 113670 | 10 MM 194 MM | In distribution |
| 113065 | 54MM HEAD Ø 24MM HEIGHT 58MM Ø OF CURV | In distribution |
| 12-113562 | 12 MM 122MM LONG | In distribution |
| 11-113558 | 8 mm 122mm Long | In distribution |
| 407327 | 7 mm | In distribution |
| 113617 | 17 mm 55mm Long | In distribution |
| 113629 | 9 mm 83mm Long | In distribution |
| 407309 | In distribution | |
| 407034 | 16MM OR 17MM SLEEVE INSERTER | In distribution |
| 407344 | In distribution | |
| 11-113562 | 12 mm 122mm Long | In distribution |
| 113042 | 46MM HEAD Ø 18MM HEIGHT 53MM Ø OF CURV | In distribution |
| 41-405805 | 5 mm | In distribution |
| 407326 | 6 mm | In distribution |
| 113024 | 38MM HEAD Ø 21MM HEIGHT 38MM Ø OF CURV | In distribution |
| 407305 | In distribution | |
| 407309 | 9 mm | In distribution |
| 113634 | 14 MM 83MM LONG | In distribution |
| 113652 | 12 mm 122mm Long | In distribution |
| 113607 | 7 mm 55mm Long | In distribution |
| 407324 | 4MM | In distribution |
| 113634 | 14 mm 83mm Long | In distribution |
| 405317 | 17 mm | In distribution |
| 407004 | 6 mm | In distribution |
| 113629 | 9 MM 83MM LONG | In distribution |
| 113637 | 17 MM 83MM LONG | In distribution |
| 110017161 | Standard | In distribution |
| 113664 | 4 MM 194 MM | In distribution |
| TI-113067 | 54MM HEAD Ø 27MM HEIGHT 55MM Ø OF CURV | In distribution |
| 113659 | 19 MM 122MM LONG | In distribution |
| 405310 | 10 mm | In distribution |
| 407329 | 9 mm | In distribution |
| TI-113048 | 46MM HEAD Ø 27MM HEIGHT 46MM Ø OF CURV | In distribution |
| 407013 | In distribution | |
| 407028 | In distribution | |
| 113633 | 13 mm 83mm Long | In distribution |
| 113613 | 13 MM 55MM LONG | In distribution |
| 113636 | 16 MM 83MM LONG | In distribution |
| 407320 | 20 mm | In distribution |
| 113674 | 14 MM 194 MM | In distribution |
| 407335 | 15 mm Standard | In distribution |
| 113640 | 20 mm 83mm Long | In distribution |
| 113636 | 16 mm 83mm Long | In distribution |
| 118001 | In distribution | |
| 407313 | In distribution | |
| 113077 | 58MM HEAD Ø 27MM HEIGHT 61MM Ø OF CURV | In distribution |
| 113624 | 4 mm 83mm Long | In distribution |
| 113657 | 17 mm 122mm Long | In distribution |
| 405305 | 5 mm | In distribution |
| 113631 | 11 mm 83mm Long | In distribution |
| 41-405817 | 17 mm | In distribution |
| 113617 | 17 MM 55MM LONG | In distribution |
| TI-113044 | 46MM HEAD Ø 21MM HEIGHT 50MM Ø OF CURV | In distribution |
| 113672 | 12 MM 194 MM | In distribution |
| 113610 | 10 mm 55mm Long | In distribution |
| 41-405807 | 7 mm | In distribution |
| 31-406912 | In distribution | |
| 407030 | In distribution | |
| 113660 | 20 MM 122MM LONG | In distribution |
| 113618 | 18 mm 55mm Long | In distribution |
| TI-113032 | 42MM HEAD Ø 18MM HEIGHT 46MM Ø OF CURV | In distribution |
| 407331 | 11 mm | In distribution |
| 31-406910 | 10 mm | In distribution |
| 407328 | 8 mm | In distribution |
| TI-113024 | 38MM HEAD Ø 21MM HEIGHT 38MM Ø OF CURV | In distribution |
| 407333 | 13MM | In distribution |
| 407026 | 8 mm / 9 mm | In distribution |
| 41-405819 | 19 mm | In distribution |
| 113036 | 42MM HEAD Ø 24MM HEIGHT 42MM Ø OF CURV | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 181 |
| Shoulder Innovations Humeral Short Stem System | Shoulder Innovations, Inc | 87 |
| BIO-Modular Shoulder System | Biomet Orthopedics | 41 |
| Shoulder Innovations InSet 95 Humeral Stem | Shoulder Innovations, Inc | 40 |
| Comprehensive® SRS Instrument | Biomet Orthopedics | 36 |
| Identity™ | Zimmer, Inc. | 29 |
| Comprehensive® SRS | Biomet Orthopedics | 25 |
| Inhance | Depuy (Ireland) | 25 |
| SMR Shoulder | Limacorporate | 20 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Synthes (U.S.A.) LP | 19 |
| BI-Angular System | Biomet Orthopedics | 16 |
| Global Unite | Depuy (Ireland) | 16 |
Showing 12 of 71. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112905 | 2012-05-24 |
Recalls Naming This Product
26 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 |
|---|---|---|---|---|---|---|---|
| Zimmer Orthopedics Manufacturing Limited-Galway | 510(k) number | 2025-03-03 | Class II | Nonconforming Material/Component | Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a | 90 US; 136 OUS | |
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 122 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2020-03-13 | Class II | Under Investigation by firm | There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. | 125 | 2021-07-21 |
| Biomet, Inc. | 510(k) number | 2020-02-17 | Class II | Under Investigation by firm | A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. | 14 units | 2022-05-31 |
| Biomet, Inc. | 510(k) number | 2018-10-10 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as th | 3 total | 2020-04-28 |
| Biomet, Inc. | 510(k) number | 2017-12-08 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem | 12 | 2018-09-04 |
| Biomet, Inc. | 510(k) number | 2017-12-08 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem | 12 | 2018-09-04 |
| Biomet, Inc. | 510(k) number | 2017-06-05 | Class II | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 2018-03-06 | |
| Biomet, Inc. | 510(k) number | 2017-06-05 | Class II | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 2018-03-06 | |
| 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 | 2015-04-16 | Class III | Labeling mix-ups | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. | 2 | 2016-05-16 |
| 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.