Comprehensive® Shoulder System
86 catalogue numbers from 407317, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
86catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| 510(k) | K060692 |
| Record published | 2017-07-28 |
| Record revised | 2025-10-30 (version 8) |
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 |
| Distribution end date | 2016-10-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 407317 | In distribution | |
| 113635 | 15 MM 83MM LONG | In distribution |
| 113620 | 20 MM 55MM LONG | In distribution |
| 407306 | 6 mm | In distribution |
| 113616 | 16 MM 55MM LONG | In distribution |
| 41-405809 | 9 mm | In distribution |
| 11-113558 | 8 MM 122MM LONG | In distribution |
| 113649 | 9 MM 122MM LONG | In distribution |
| 407312 | In distribution | |
| 113650 | 10 mm 122mm Long | In distribution |
| 113611 | 11 MM 55MM LONG | In distribution |
| 407328 | 8MM | In distribution |
| 113608 | 8 MM 55MM LONG | In distribution |
| 407312 | 12 mm | In distribution |
| 113638 | 18 mm 83mm Long | In distribution |
| 113022 | 38MM HEAD Ø 19MM HEIGHT 39MM Ø OF CURV | In distribution |
| 113577 | 9MM SLEEVE | In distribution |
| 113055 | 50MM HEAD Ø 24MM HEIGHT 52MM Ø OF CURV | In distribution |
| 110035767 | Standard | In distribution |
| 407005 | 7 mm | In distribution |
| 113647 | 7 MM 122MM LONG | In distribution |
| 113624 | 4 MM 83MM LONG | In distribution |
| 41-405812 | 12 mm | In distribution |
| 113625 | 5 mm 83mm Long | In distribution |
| 407307 | In distribution | |
| 405314 | 14 mm | In distribution |
| 12-113564 | 14 MM 122MM LONG | In distribution |
| 113609 | 9 mm 55mm Long | In distribution |
| 12-113554 | 4 MM 122MM LONG | In distribution |
| 407009 | 11MM | In distribution |
| 407311 | In distribution | |
| 407330 | 10 mm | In distribution |
| 31-406906 | 6 mm | In distribution |
| 407314 | In distribution | |
| 113581 | 13MM SLEEVE | In distribution |
| 113053 | 50MM HEAD Ø 21MM HEIGHT 57MM Ø OF CURV | In distribution |
| 407314 | 14 mm | In distribution |
| 407304 | In distribution | |
| 11-113554 | 4 mm 122mm Long | In distribution |
| 11-113562 | 12 MM 122MM LONG | In distribution |
| 113606 | 6 mm 55mm Long | In distribution |
| 113584 | 16MM SLEEVE | In distribution |
| 113574 | 6MM SLEEVE | In distribution |
| 113075 | 58MM HEAD Ø 24MM HEIGHT 64MM Ø OF CURV | In distribution |
| 407032 | 14 mm / 15 mm | In distribution |
| 113626 | 6 mm 83mm Long | In distribution |
| 113615 | 15 mm 55mm Long | In distribution |
| 31-406901 | In distribution | |
| 41-405818 | 18 mm | In distribution |
| 407317 | 17 mm | In distribution |
| 407336 | 16MM | In distribution |
| 407008 | 10MM | In distribution |
| 407006 | 8 mm | In distribution |
| 113604 | 4 mm 55mm Long | In distribution |
| 11-113556 | 6 MM 122MM LONG | In distribution |
| 31-406912 | 12 mm | In distribution |
| 113645 | 5 mm 122mm Long | In distribution |
| 113620 | 20 mm 55mm Long | In distribution |
| 113655 | 15 mm 122mm Long | In distribution |
| 41-405820 | 20 mm | In distribution |
| 407335 | 15MM | In distribution |
| 407311 | 11 mm | In distribution |
| 113660 | 20 mm 122mm Long | In distribution |
| TI-113053 | 50MM HEAD Ø 21MM HEIGHT 57MM Ø OF CURV | In distribution |
| 41-405806 | 6 mm | In distribution |
| 113619 | 19 MM 55MM LONG | In distribution |
| 11-113556 | 6 mm 122mm Long | In distribution |
| 407346 | In distribution | |
| 407026 | In distribution | |
| TI-113065 | 54MM HEAD Ø 24MM HEIGHT 58MM Ø OF CURV | In distribution |
| 407332 | 12MM | In distribution |
| 407032 | In distribution | |
| 31-406908 | 8 mm | In distribution |
| 113576 | 8MM SLEEVE | In distribution |
| 41-405813 | 13 mm | In distribution |
| 113608 | 8 mm 55mm Long | In distribution |
| 113614 | 14 mm 55mm Long | In distribution |
| 405318 | 18 mm | In distribution |
| 113628 | 8 mm 83mm Long | In distribution |
| 407329 | 9MM | In distribution |
| TI-113055 | 50MM HEAD Ø 24MM HEIGHT 52MM Ø OF CURV | In distribution |
| SSI000168 | MD | Withdrawn |
| SSI000166 | SM | Withdrawn |
| SSI001963 | Withdrawn | |
| SSI001761 | SM | Withdrawn |
| SSI001965 | LG | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
| Catalyst CSR Shoulder System | Catalyst Orthoscience Inc | 39 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223631 | 2023-07-12 |
| K023063 | 2002-12-13 |
| K020045 | 2002-01-30 |
Recalls Naming This Product
28 recalls name this product by its own identifiers, the UDI on its label or 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. | UDI-DI | 2022-01-07 | Class II | Process control | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were poro | 10 units | 2023-04-13 |
| Biomet, Inc. | UDI-DI | 2022-01-07 | Class II | Process control | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were poro | 11 units | 2023-04-13 |
| 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 | 2017-04-26 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped des | 16 | 2018-03-30 |
| 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 |
| Biomet, Inc. | 510(k) number | 2008-03-13 | Not classified | Device Design | The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implan | 189 | 2008-10-15 |
| Biomet, Inc. | 510(k) number | 0012-12-06 | Class II | Nonconforming Material/Component | Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following thre | 1050 | 2013-11-08 |
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.