Reunion
Expanding Insert Assembly - Large, Constrained
9manufacturers in China registered for this device type
321catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2025-04-14 (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 |
| Sizes | Length 4 to 105 mm |
| Distribution end date | 2022-11-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5901-IC-3610 | Diameter: 36.0 Millimeter | In distribution |
| 5573-6532 | Length 32.0 mm | In distribution |
| 5901-IS-4012 | Diameter: 40.0 Millimeter | In distribution |
| 5901-IC-4012 | Diameter: 40.0 Millimeter | In distribution |
| 5552-E-4014 | Thickness: 14.0 Millimeter | In distribution |
| 5552-S-5622 | Thickness: 22.0 Millimeter | In distribution |
| 5567-P-3019 | Diameter: 19.0 Millimeter | In distribution |
| 5569-P-2007 | Stem Length: 113.0 Millimeter | In distribution |
| 5552-E-4416 | Thickness: 16.0 Millimeter | In distribution |
| 5901-IS-4006 | Diameter: 40.0 Millimeter | In distribution |
| 5568-0012 | Distal Diameter: 12.0 Millimeter | In distribution |
| 5570-4010 | Diameter: 40.0 Millimeter | In distribution |
| 5901-IC-4010 | Diameter: 40.0 Millimeter | In distribution |
| 5901-IC-3206 | Diameter: 32.0 Millimeter | In distribution |
| 5567-P-3013 | Diameter: 13.0 Millimeter | In distribution |
| 5569-P-2010 | Stem Length: 123.0 Millimeter | In distribution |
| 5572-4520 | Diameter: 5.0 Millimeter | In distribution |
| 5571-C-3208 | Thickness: 8.0 Millimeter | In distribution |
| 5569-C-2108L | Distal Diameter: 8.0 Millimeter | In distribution |
| 5571-C-3212-E | Diameter: 32.0 Millimeter | In distribution |
| 5901-LG-36IC | Diameter: 36.0 Millimeter | In distribution |
| 5571-C-4012 | Diameter: 40.0 Millimeter | In distribution |
| 5552-S-4416 | Diameter: 44.0 Millimeter | In distribution |
| 5571-S-3208 | Diameter: 32.0 Millimeter | In distribution |
| 5901-CP-4004 | Diameter: 40.0 Millimeter | In distribution |
| 5901-2E-3606 | Thickness: 6.0 Millimeter | In distribution |
| 5571-S-3610-E | Thickness: 10.0 Millimeter | In distribution |
| 5567-C-3018 | Diameter: 18.0 Millimeter | In distribution |
| 5901-IC-3212 | Diameter: 32.0 Millimeter | In distribution |
| 5572-4524 | Length 24.0 mm | In distribution |
| 5572-4548 | Diameter: 5.0 Millimeter | In distribution |
| 5901-IC-4006 | Diameter: 40.0 Millimeter | In distribution |
| 5552-S-4818 | Thickness: 18.0 Millimeter | In distribution |
| 5569-P-2015 | Distal Diameter: 15.0 Millimeter | In distribution |
| 5901-1126 | Diameter: 3.1 Millimeter | In distribution |
| 5542-P-0040 | Diameter: 40.0 Millimeter | In distribution |
| 5901-6084 | In distribution | |
| 5552-E-5223 | Diameter: 52.0 Millimeter | In distribution |
| 5901-IC-3606 | Thickness: 6.0 Millimeter | In distribution |
| 5552-E-4824 | Thickness: 24.0 Millimeter | In distribution |
| 5552-E-4821 | Thickness: 21.0 Millimeter | In distribution |
| 5901-SM-32IC | Diameter: 32.0 Millimeter | In distribution |
| 5571-S-3212-E | Thickness: 12.0 Millimeter | In distribution |
| 5572-2800 | Diameter: 28.0 Millimeter | In distribution |
| 5567-C-3007 | Length 91.0 mm | In distribution |
| 5570-3204 | Diameter: 32.0 Millimeter | In distribution |
| 5571-C-4010-E | Diameter: 40.0 Millimeter | In distribution |
| 5901-C-3606 | Thickness: 6.0 Millimeter | In distribution |
| 5571-S-3206-E | Diameter: 32.0 Millimeter | In distribution |
| 5571-C-3208-E | Thickness: 8.0 Millimeter | In distribution |
| 5901-LG-40IC | Diameter: 40.0 Millimeter | In distribution |
| 5568-0013 | Stem Length: 128.0 Millimeter | In distribution |
| 5901-1116 | In distribution | |
| 5573-C-3206 | Diameter: 32.0 Millimeter | In distribution |
| 5901-1184 | In distribution | |
| 5571-C-3210-E | Diameter: 32.0 Millimeter | In distribution |
| 5552-E-5628 | Diameter: 56.0 Millimeter | In distribution |
| 5571-C-3604 | Diameter: 36.0 Millimeter | In distribution |
| 5573-2E-4006 | Offset: 6.0 Millimeter | In distribution |
| 5901-6086 | In distribution | |
| 5573-4E-4006 | Diameter: 40.0 Millimeter | In distribution |
| 5552-S-5226 | Thickness: 26.0 Millimeter | In distribution |
| 5572-4552 | Diameter: 5.0 Millimeter | In distribution |
| 5901-LG-40IS | Diameter: 40.0 Millimeter | In distribution |
| 5571-S-3608 | Thickness: 8.0 Millimeter | In distribution |
| 5573-C-4002 | Diameter: 40.0 Millimeter | In distribution |
| 5901-4E-4002 | Thickness: 2.0 Millimeter | In distribution |
| 5542-K-0048-E | In distribution | |
| 5573-4E-4002 | Offset: 2.0 Millimeter | In distribution |
| 5569-C-2013 | Stem Length: 128.0 Millimeter | In distribution |
| 5542-P-0052 | Diameter: 52.0 Millimeter | In distribution |
| 5571-S-4004 | Diameter: 40.0 Millimeter | In distribution |
| 5573-C-3606 | Diameter: 36.0 Millimeter | In distribution |
| 5552-S-4821 | Diameter: 48.0 Millimeter | In distribution |
| 5901-E-5217 | Diameter: 54.0 Millimeter | In distribution |
| 5572-4540 | Diameter: 5.0 Millimeter | In distribution |
| 5552-E-4020 | Diameter: 40.0 Millimeter | In distribution |
| 5552-E-4419 | Diameter: 44.0 Millimeter | In distribution |
| 5569-C-2008 | Stem Length: 118.0 Millimeter | In distribution |
| 5901-2E-4002 | Diameter: 40.0 Millimeter | In distribution |
| 5571-C-3206 | Thickness: 6.0 Millimeter | In distribution |
| 5570-3610 | Thickness: 10.0 Millimeter | In distribution |
| 5569-C-2012 | Stem Length: 128.0 Millimeter | In distribution |
| 5571-S-3210 | Thickness: 10.0 Millimeter | In distribution |
| 5571-S-4006 | Diameter: 40.0 Millimeter | In distribution |
| 5570-3604 | Diameter: 36.0 Millimeter | In distribution |
| 5901-IC-4004 | Diameter: 40.0 Millimeter | In distribution |
| 5901-6077 | In distribution | |
| 5552-S-4419 | Diameter: 44.0 Millimeter | In distribution |
| 5901-C-3602 | Diameter: 36.0 Millimeter | In distribution |
| 5901-6073 | In distribution | |
| 5901-1168 | In distribution | |
| 5572-4536 | Diameter: 5.0 Millimeter | In distribution |
| 5901-1119 | In distribution | |
| 5552-S-5223 | Thickness: 23.0 Millimeter | In distribution |
| 5568-0014 | Distal Diameter: 14.0 Millimeter | In distribution |
| 5567-C-3016 | Diameter: 16.0 Millimeter | In distribution |
| 5542-K-0056-E | In distribution | |
| 5571-C-4012-E | Thickness: 12.0 Millimeter | In distribution |
| 5571-S-3606 | Diameter: 36.0 Millimeter | In distribution |
| 5571-S-3610 | Diameter: 36.0 Millimeter | In distribution |
| 5901-1118 | In distribution | |
| 5901-IS-3206 | Thickness: 6.0 Millimeter | In distribution |
| 5901-SM-32IS | Diameter: 32.0 Millimeter | In distribution |
| 5571-S-3212 | Diameter: 32.0 Millimeter | In distribution |
| 5542-K-0056 | Diameter: 56.0 Millimeter | In distribution |
| 5571-C-3610 | Thickness: 10.0 Millimeter | In distribution |
| 5552-S-4422 | Diameter: 44.0 Millimeter | In distribution |
| 5571-C-4008 | Thickness: 8.0 Millimeter | In distribution |
| 5568-0009 | Distal Diameter: 9.0 Millimeter | In distribution |
| 5552-S-5217 | Diameter: 52.0 Millimeter | In distribution |
| 5573-2E-3606 | Offset: 6.0 Millimeter | In distribution |
| 5901-CP-3210 | Thickness: 10.0 Millimeter | In distribution |
| 5573-6524 | Length 24.0 mm | In distribution |
| 5573-6536 | Diameter: 7.0 Millimeter | In distribution |
| 5571-C-3608 | Diameter: 36.0 Millimeter | In distribution |
| 5573-C-3602 | Diameter: 36.0 Millimeter | In distribution |
| 5901-1114 | In distribution | |
| 5901-IS-3612 | Thickness: 12.0 Millimeter | In distribution |
| 5569-P-2017 | Distal Diameter: 17.0 Millimeter | In distribution |
| 5552-S-5220 | Diameter: 52.0 Millimeter | In distribution |
| 5569-P-2012 | Stem Length: 128.0 Millimeter | In distribution |
| 5901-1169 | In distribution | |
| 5552-S-4815 | Thickness: 15.0 Millimeter | In distribution |
| 5571-C-4010 | Thickness: 10.0 Millimeter | In distribution |
| 5571-S-4010 | Thickness: 10.0 Millimeter | In distribution |
| 5901-2E-4006 | Diameter: 40.0 Millimeter | In distribution |
| 5567-C-3012 | Length 96.0 mm | In distribution |
| 5901-IC-4008 | Thickness: 8.0 Millimeter | In distribution |
| 5901-1123 | In distribution | |
| 5901-CP-40EX | Diameter: 40.0 Millimeter | In distribution |
| 5542-P-0044 | Diameter: 44.0 Millimeter | In distribution |
| 5571-S-4008 | Diameter: 40.0 Millimeter | In distribution |
| 5569-P-2011 | Stem Length: 123.0 Millimeter | In distribution |
| 5901-6071 | In distribution | |
| 5901-1196 | In distribution | |
| 5542-P-0052-E | In distribution | |
| 5901-IC-3608 | Thickness: 8.0 Millimeter | In distribution |
| 5567-P-3015 | Length 99.0 mm | In distribution |
| 5552-E-4818 | Thickness: 18.0 Millimeter | In distribution |
| 5552-S-5619 | Thickness: 19.0 Millimeter | In distribution |
| 5569-P-2013 | Stem Length: 128.0 Millimeter | In distribution |
| 5567-C-3010 | Length 94.0 mm | In distribution |
| 5901-IC-3612 | Thickness: 12.0 Millimeter | In distribution |
| 5572-2802 | In distribution | |
| 5569-C-2112L | Distal Diameter: 12.0 Millimeter | In distribution |
| 5569-C-2006 | Stem Length: 113.0 Millimeter | In distribution |
| 5901-1100 | In distribution | |
| 5571-C-4004 | Diameter: 40.0 Millimeter | In distribution |
| 5901-SM-36IS | Diameter: 36.0 Millimeter | In distribution |
| 5901-6091 | In distribution | |
| 5901-6079 | In distribution | |
| 5572-4516 | Diameter: 5.0 Millimeter | In distribution |
| 5901-IS-4004 | Diameter: 40.0 Millimeter | In distribution |
| 5571-C-4008-E | Thickness: 8.0 Millimeter | In distribution |
| 5901-6096 | In distribution | |
| 5901-CP-32EX | Diameter: 32.0 Millimeter | In distribution |
| 5569-P-2016 | Distal Diameter: 16.0 Millimeter | In distribution |
| 5552-E-5226 | Diameter: 52.0 Millimeter | In distribution |
| 5571-S-3204-E | Diameter: 32.0 Millimeter | In distribution |
| 5901-IC-3204 | Diameter: 32.0 Millimeter | In distribution |
| 5901-1122 | In distribution | |
| 5552-S-4014 | Diameter: 40.0 Millimeter | In distribution |
| 5571-C-3210 | Diameter: 32.0 Millimeter | In distribution |
| 5901-IS-3608 | Thickness: 8.0 Millimeter | In distribution |
| 5901-4E-4006 | Diameter: 40.0 Millimeter | In distribution |
| 5901-IC-3210 | Thickness: 10.0 Millimeter | In distribution |
| 5552-S-5625 | Diameter: 56.0 Millimeter | In distribution |
| 5569-C-2010 | Distal Diameter: 10.0 Millimeter | In distribution |
| 5567-C-3013 | Diameter: 13.0 Millimeter | In distribution |
| 5568-0015 | Stem Length: 133.0 Millimeter | In distribution |
| 5571-C-3204 | Diameter: 32.0 Millimeter | In distribution |
| 5571-C-3212 | Thickness: 12.0 Millimeter | In distribution |
| 5567-C-3015 | Length 99.0 mm | In distribution |
| 5542-P-0056 | Diameter: 56.0 Millimeter | In distribution |
| 5901-6093 | In distribution | |
| 5542-K-0052-E | In distribution | |
| 5567-P-3008 | Length 92.0 mm | In distribution |
| 5567-P-3014 | Length 98.0 mm | In distribution |
| 5567-P-3017 | Length 102.0 mm | In distribution |
| 5901-1198 | In distribution | |
| 5552-E-4017 | Thickness: 17.0 Millimeter | In distribution |
| 5572-4528 | Length 28.0 mm | In distribution |
| 5901-IS-4008 | Diameter: 40.0 Millimeter | In distribution |
| 5573-6528 | Diameter: 7.0 Millimeter | In distribution |
| 5571-S-3604 | Diameter: 36.0 Millimeter | In distribution |
| 5552-S-5628 | Thickness: 28.0 Millimeter | In distribution |
| 5901-CP-4010 | Diameter: 40.0 Millimeter | In distribution |
| 5567-C-3009 | Length 93.0 mm | In distribution |
| 5552-S-4017 | Thickness: 17.0 Millimeter | In distribution |
| 5901-CP-3204 | Diameter: 32.0 Millimeter | In distribution |
| 5552-E-5619 | Thickness: 19.0 Millimeter | In distribution |
| 5552-E-5625 | Thickness: 25.0 Millimeter | In distribution |
| 5571-S-3206 | Thickness: 6.0 Millimeter | In distribution |
| 5901-CP-36EX | Diameter: 36.0 Millimeter | In distribution |
| 5567-P-3016 | Length 101.0 mm | In distribution |
| 5571-S-4012 | Thickness: 12.0 Millimeter | In distribution |
| 5571-S-3204 | Diameter: 32.0 Millimeter | In distribution |
| 5901-C-3206 | Thickness: 6.0 Millimeter | In distribution |
| 5901-6090 | In distribution | |
| 5901-1197 | In distribution | |
| 5567-P-3020 | Diameter: 20.0 Millimeter | In distribution |
| 5571-S-3606-E | Diameter: 36.0 Millimeter | In distribution |
| 5901-1101 | In distribution | |
| 5901-1175 | In distribution | |
| 5569-C-2011 | Stem Length: 123.0 Millimeter | In distribution |
| 5567-C-3014 | Diameter: 14.0 Millimeter | In distribution |
| 5571-C-3612-E | Diameter: 36.0 Millimeter | In distribution |
| 5901-SM-40IC | Diameter: 40.0 Millimeter | In distribution |
| 5901-IC-3604 | Thickness: 4.0 Millimeter | In distribution |
| 5552-S-4020 | Diameter: 40.0 Millimeter | In distribution |
| 5901-6078 | In distribution | |
| 5569-C-2009 | Distal Diameter: 9.0 Millimeter | In distribution |
| 5567-P-3011 | Diameter: 11.0 Millimeter | In distribution |
| 5569-P-2014 | Distal Diameter: 14.0 Millimeter | In distribution |
| 5571-C-4006 | Thickness: 6.0 Millimeter | In distribution |
| 5542-K-0040 | Diameter: 40.0 Millimeter | In distribution |
| 5901-IC-3208 | Diameter: 32.0 Millimeter | In distribution |
| 5573-6544 | Diameter: 7.0 Millimeter | In distribution |
| 5567-P-3009 | Length 93.0 mm | In distribution |
| 5567-P-3010 | Length 94.0 mm | In distribution |
| 5569-C-2007 | Distal Diameter: 7.0 Millimeter | In distribution |
| 5542-P-0040-E | In distribution | |
| 5567-C-3006 | Length 89.0 mm | In distribution |
| 5901-1115 | In distribution | |
| 5542-K-0052 | Diameter: 52.0 Millimeter | In distribution |
| 5901-IS-3610 | Thickness: 10.0 Millimeter | In distribution |
| 5567-C-3011 | Length 95.0 mm | In distribution |
| 5552-S-4824 | Diameter: 48.0 Millimeter | In distribution |
| 5901-6072 | In distribution | |
| 5901-1106 | In distribution | |
| 5570-4004 | Thickness: 4.0 Millimeter | In distribution |
| 5901-LG-36IS | Diameter: 36.0 Millimeter | In distribution |
| 5568-0008 | Distal Diameter: 8.0 Millimeter | In distribution |
| 5901-IS-3606 | Diameter: 36.0 Millimeter | In distribution |
| 5571-S-4010-E | Thickness: 10.0 Millimeter | In distribution |
| 5901-C-4002 | Thickness: 2.0 Millimeter | In distribution |
| 5552-E-5622 | Diameter: 56.0 Millimeter | In distribution |
| 5901-IS-3208 | Thickness: 8.0 Millimeter | In distribution |
| 5901-LG-32IS | Diameter: 32.0 Millimeter | In distribution |
| 5901-1117 | In distribution | |
| 5568-0011 | Distal Diameter: 11.0 Millimeter | In distribution |
| 5567-P-3018 | Length 103.0 mm | In distribution |
| 5567-C-3017 | Length 102.0 mm | In distribution |
| 5571-C-4004-E | Thickness: 4.0 Millimeter | In distribution |
| 5542-K-0044 | Diameter: 44.0 Millimeter | In distribution |
| 5901-6076 | In distribution | |
| 5572-4544 | Length 44.0 mm | In distribution |
| 5573-C-3202 | Diameter: 32.0 Millimeter | In distribution |
| 5552-E-5220 | Thickness: 20.0 Millimeter | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
| Cofield | Smith & Nephew, Inc. | 76 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210861 | 2021-09-03 |
| K202289 | 2020-12-16 |
| K183039 | 2019-02-15 |
| K181742 | 2018-09-27 |
| K161863 | 2016-11-23 |
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.