Tornier Flex Shoulder System
187 catalogue numbers from DWG156, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
187catalogue numbers in this listing
24510(k) clearances naming this product code
6recalls on this 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 | Tornier Inc., United States |
|---|---|
| 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, Exporter |
| Record published | 2022-03-25 |
| Record revised | 2025-03-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 33 to 55.4 mm; angle 7.5 to 137.5 °; height 13 to 27 mm; length 66 to 125 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DWG156 | Outer Diameter 54 mm | In distribution |
| DWF601B | Size 1B | In distribution |
| DWF252 | Eccentric: LOW (1.5) | In distribution |
| DWG053 | Outer Diameter 51 mm | In distribution |
| DWF601A | Length 66 mm | In distribution |
| DWF041 | Eccentric: LOW (1.5) | In distribution |
| DWF604B | Size 4B | In distribution |
| DWF716A | Angle 127.5 ° | In distribution |
| DWF391C | Angle 7.5 ° | In distribution |
| DWF392B | Thickness +9mm | In distribution |
| DWG149 | Eccentric: HIGH (4) | In distribution |
| DWF353 | Height 23 mm | In distribution |
| DWF615C | Length 109 mm | In distribution |
| DWF151 | Eccentric: HIGH (4) | In distribution |
| DWF618C | Size 8C | In distribution |
| DWF421A | Outer Diameter 42 mm | In distribution |
| DWF702C | Size 2C | In distribution |
| DWG046 | Eccentric: LOW (1.5) | In distribution |
| DWF422B | Thickness +9mm | In distribution |
| DWF611A | Size 1A | In distribution |
| DWG048 | Outer Diameter 48 mm | In distribution |
| DWF395A | Outer Diameter 39 mm | In distribution |
| DWF614B | Length 104 mm | In distribution |
| DWG147 | Outer Diameter 45 mm | In distribution |
| DWF358B | Outer Diameter 33 mm | In distribution |
| DWF613A | Size 3A | In distribution |
| DWF358A | Outer Diameter 33 mm | In distribution |
| DWF425C | Outer Diameter 42 mm | In distribution |
| DWF424C | Outer Diameter 42 mm | In distribution |
| DWF362A | Outer Diameter 36 mm | In distribution |
| DWG057 | Height 24 mm | In distribution |
| DWF348 | Eccentric: HIGH (4) | In distribution |
| DWF043 | Outer Diameter 43 mm | In distribution |
| DWF394B | Outer Diameter 39 mm | In distribution |
| DWF365A | Outer Diameter 36 mm | In distribution |
| DWF356C | Thickness +6mm | In distribution |
| DWF501 | Thickness +6 mm | In distribution |
| DWG153 | Outer Diameter 51 mm | In distribution |
| DWF046 | Outer Diameter 46 mm | In distribution |
| DWF511 | Thickness +6 mm | In distribution |
| DWF512 | Eccentric: LOW (1.5) | In distribution |
| DWF362C | Thickness +9mm | In distribution |
| DWF702A | Size 2A | In distribution |
| DWF708C | Length 90 mm | In distribution |
| DWF618B | Length 125 mm | In distribution |
| DWF607B | Length 90 mm | In distribution |
| DWF706C | Size 6C | In distribution |
| DWF143 | Eccentric: HIGH (3.5) | In distribution |
| DWF617A | Angle 127.5 ° | In distribution |
| DWG141 | Height 15 mm | In distribution |
| DWF425B | Angle 12.5 ° | In distribution |
| DWG056 | Height 24 mm | In distribution |
| DWF500 | Thickness +0 mm | In distribution |
| DWF614C | Angle 137.5 ° | In distribution |
| DWF356A | Angle 17.5 ° | In distribution |
| DWF602A | Angle 127.5 ° | In distribution |
| DWF603A | Size 3A | In distribution |
| DWF605A | Size 5A | In distribution |
| DWF253 | Outer Diameter 52 mm | In distribution |
| DWG150 | Height 20 mm | In distribution |
| DWG152 | Height 20 mm | In distribution |
| DWF603B | Size 3B | In distribution |
| DWF615A | Length 109 mm | In distribution |
| DWF612C | Length 93 mm | In distribution |
| DWG050 | Outer Diameter 48 mm | In distribution |
| DWF606A | Size 6A | In distribution |
| DWF602B | Size 2B | In distribution |
| DWG052 | Outer Diameter 51 mm | In distribution |
| DWF351 | Eccentric: HIGH (4) | In distribution |
| DWF611C | Angle 137.5 ° | In distribution |
| DWF361B | Outer Diameter 36 mm | In distribution |
| DWG139 | Outer Diameter 39 mm | In distribution |
| DWF613B | Length 98 mm | In distribution |
| DWG047 | Eccentric: LOW (1.5) | In distribution |
| DWF613C | Length 98 mm | In distribution |
| DWG145 | Height 15 mm | In distribution |
| DWF365C | Outer Diameter 36 mm | In distribution |
| DWF051 | Height 19 mm | In distribution |
| DWF361C | Angle 7.5 ° | In distribution |
| DWG146 | Outer Diameter 45 mm | In distribution |
| DWF153 | Eccentric: HIGH (4) | In distribution |
| DWF424B | Outer Diameter 42 mm | In distribution |
| DWF607C | Size 7C | In distribution |
| DWF037 | Eccentric: LOW (1.5) | In distribution |
| DWF053 | Eccentric: LOW (1.5) | In distribution |
| DWF364B | Thickness +6mm | In distribution |
| DWF716B | Length 109 mm | In distribution |
| DWF612A | Size 2A | In distribution |
| DWF712A | Length 88 mm | In distribution |
| DWF608A | Angle 127.5 ° | In distribution |
| DWF502 | Thickness +12 mm | In distribution |
| DWF356B | Outer Diameter 33 mm | In distribution |
| DWF603C | Size 3C | In distribution |
| DWF424A | Angle 17.5 ° | In distribution |
| DWF139 | Eccentric: HIGH (3.5) | In distribution |
| DWF712C | Angle 137.5 ° | In distribution |
| DWF608C | Length 94 mm | In distribution |
| DWF137 | Outer Diameter 37 mm | In distribution |
| DWF708B | Size 8B | In distribution |
| DWF708A | Length 90 mm | In distribution |
| DWF522 | Eccentric: HIGH (3.5) | In distribution |
| DWF616B | Angle 132.5 ° | In distribution |
| DWG051 | Outer Diameter 51 mm | In distribution |
| DWF718A | Length 120 mm | In distribution |
| DWG039 | Eccentric: LOW (1.5) | In distribution |
| DWF520 | Eccentric: HIGH (3.5) | In distribution |
| DWG144 | Outer Diameter 42 mm | In distribution |
| DWF714B | Size 4B | In distribution |
| DWF521 | Thickness +6 mm | In distribution |
| DWF704A | Angle 127.5 ° | In distribution |
| DWF248 | Outer Diameter 48 mm | In distribution |
| DWF141 | Outer Diameter 41 mm | In distribution |
| DWF048 | Outer Diameter 48 mm | In distribution |
| DWF714A | Angle 127.5 ° | In distribution |
| DWF608B | Angle 132.5 ° | In distribution |
| DWF617B | Length 120 mm | In distribution |
| DWF604C | Length 78 mm | In distribution |
| DWG049 | Eccentric: LOW (1.5) | In distribution |
| DWF604A | Size 4A | In distribution |
| DWF616C | Size 6C | In distribution |
| DWF612B | Size 2B | In distribution |
| DWF250 | Eccentric: LOW (1.5) | In distribution |
| DWG042 | Outer Diameter 42 mm | In distribution |
| DWF339 | Eccentric: HIGH (3.5) | In distribution |
| DWF605B | Length 82 mm | In distribution |
| DWF706B | Angle 132.5 ° | In distribution |
| DWF706A | Angle 127.5 ° | In distribution |
| DWG155 | Height 21 mm | In distribution |
| DWF718B | Length 120 mm | In distribution |
| DWF618A | Length 125 mm | In distribution |
| DWF050 | Outer Diameter 50 mm | In distribution |
| DWF714C | Length 98 mm | In distribution |
| DWF154 | Eccentric: HIGH (4) | In distribution |
| DWF361A | Thickness +6mm | In distribution |
| DWF364C | Outer Diameter 36 mm | In distribution |
| DWF146 | Outer Diameter 46 mm | In distribution |
| DWF039 | Eccentric: LOW (1.5) | In distribution |
| DWF357B | Angle 12.5 ° | In distribution |
| DWG154 | Outer Diameter 54 mm | In distribution |
| DWF718C | Size 8C | In distribution |
| DWG054 | Eccentric: LOW (1.5) | In distribution |
| DWG043 | Height 16 mm | In distribution |
| DWF148 | Outer Diameter 48 mm | In distribution |
| DWF606B | Angle 132.5 ° | In distribution |
| DWF702B | Angle 132.5 ° | In distribution |
| DWF421B | Outer Diameter 42 mm | In distribution |
| DWF606C | Angle 137.5 ° | In distribution |
| DWF611B | Angle 132.5 ° | In distribution |
| DWG045 | Outer Diameter 45 mm | In distribution |
| DWF704B | Angle 132.5 ° | In distribution |
| DWG143 | Height 16 mm | In distribution |
| DWG142 | Eccentric: HIGH (3.5) | In distribution |
| DWF422A | Outer Diameter 42 mm | In distribution |
| DWF155 | Height 27 mm | In distribution |
| DWF251 | Height 19 mm | In distribution |
| DWF605C | Angle 137.5 ° | In distribution |
| DWF607A | Angle 127.5 ° | In distribution |
| DWF712B | Length 88 mm | In distribution |
| DWF150 | Outer Diameter 50 mm | In distribution |
| DWG041 | Height 15 mm | In distribution |
| DWF510 | Thickness +0 mm | In distribution |
| DWF364A | Thickness +6mm | In distribution |
| DWG151 | Eccentric: HIGH (4) | In distribution |
| DWF243 | Outer Diameter 43 mm | In distribution |
| DWF054 | Height 23 mm | In distribution |
| DWF716C | Length 109 mm | In distribution |
| DWF601C | Size 1C | In distribution |
| DWF602C | Size 2C | In distribution |
| DWF425A | Outer Diameter 42 mm | In distribution |
| DWF152 | Outer Diameter 52 mm | In distribution |
| DWG148 | Outer Diameter 48 mm | In distribution |
| DWF616A | Angle 127.5 ° | In distribution |
| DWF239 | Outer Diameter 39 mm | In distribution |
| DWF422C | Outer Diameter 42 mm | In distribution |
| DWF617C | Angle 137.5 ° | In distribution |
| DWF615B | Size 5B | In distribution |
| DWF704C | Length 74 mm | In distribution |
| DWF055 | Height 27 mm | In distribution |
| DWF362B | Angle 12.5 ° | In distribution |
| DWF365B | Thickness +9mm | In distribution |
| DWG055 | Outer Diameter 54 mm | In distribution |
| DWG044 | Height 18 mm | In distribution |
| DWF614A | Length 104 mm | In distribution |
| DWG157 | Outer Diameter 55.4 mm | In distribution |
| DWF052 | Height 19 mm | In distribution |
| DWF237 | Height 13.5 mm | In distribution |
| DWF421C | Angle 7.5 ° | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| 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 |
|---|---|
| K260721 | 2026-07-22 |
| K191318 | 2019-06-14 |
| K181420 | 2018-09-20 |
| K160975 | 2016-06-10 |
| K150583 | 2015-04-23 |
| K121493 | 2012-06-20 |
| K120794 | 2012-04-13 |
| K113413 | 2012-03-09 |
| K111902 | 2011-11-03 |
| K110865 | 2011-04-27 |
| K102924 | 2011-01-31 |
| K103007 | 2010-11-09 |
| K082120 | 2008-10-24 |
| K081707 | 2008-07-17 |
| K060209 | 2006-03-02 |
| K043077 | 2004-12-17 |
| K041339 | 2004-06-17 |
| K032679 | 2003-12-15 |
| K012212 | 2001-08-15 |
| K003728 | 2000-12-20 |
| K994393 | 2000-06-22 |
| K994392 | 2000-03-10 |
| K980244 | 1999-08-23 |
| K952928 | 1995-09-27 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-03-05 | Class II | Labeling design | Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. | 233 | |
| 2025-12-19 | Class II | Labeling mix-ups | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw i | 427 | |
| 2023-06-12 | Class II | Under Investigation by firm | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. | 55 units | |
| 2023-06-12 | Class II | Under Investigation by firm | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. | 55 units | |
| 2021-05-28 | Class II | Employee error | Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness. | 20 | 2023-04-14 |
| 2016-09-19 | Class II | Component design/selection | Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem. | 30 | 2018-05-31 |
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.