DJO Surgical
Altivate Reverse, Small Socket Insert, 36MM Semi Constrained
8manufacturers in China registered for this device type
70catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K162024 |
| Record published | 2018-05-15 |
| Record revised | 2026-03-23 (version 14) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 804-07-541 | In distribution | |
| 804-07-046 | In distribution | |
| 804-46-218 | In distribution | |
| 530-10-175 | In distribution | |
| 508-03-036 | In distribution | |
| 530-12-108 | In distribution | |
| 530-14-175 | In distribution | |
| 804-54-220 | In distribution | |
| 530-16-108 | In distribution | |
| 530-14-220 | In distribution | |
| 520-08-000 | In distribution | |
| 508-03-032 | In distribution | |
| 530-12-048 | In distribution | |
| 530-10-220 | In distribution | |
| 804-07-380 | In distribution | |
| 804-07-461 | In distribution | |
| 533-12-175 | In distribution | |
| 530-10-108 | In distribution | |
| 530-08-048 | In distribution | |
| 509-02-032 | In distribution | |
| 509-03-436 | In distribution | |
| 509-03-036 | In distribution | |
| 804-07-151 | In distribution | |
| 530-16-108 | In distribution | |
| 520-46-216 | In distribution | |
| 509-02-040 | In distribution | |
| 530-08-220 | In distribution | |
| 530-14-108 | In distribution | |
| 533-10-108 | In distribution | |
| 530-18-220 | In distribution | |
| 533-01-002 | In distribution | |
| 804-07-180 | In distribution | |
| 804-07-134 | In distribution | |
| 509-03-444 | In distribution | |
| 521-07-250 | In distribution | |
| 508-02-044 | In distribution | |
| 530-08-108 | In distribution | |
| 530-06-220 | In distribution | |
| 530-18-108 | In distribution | |
| 520-42-218 | In distribution | |
| 804-07-004 | In distribution | |
| 804-07-338 | In distribution | |
| 530-06-175 | In distribution | |
| 533-10-220 | In distribution | |
| 804-07-125 | In distribution | |
| 520-42-318 | In distribution | |
| 530-18-175 | In distribution | |
| 530-08-175 | In distribution | |
| 530-16-220 | In distribution | |
| 804-07-160 | In distribution | |
| 509-03-440 | In distribution | |
| 509-02-432 | In distribution | |
| 530-16-175 | In distribution | |
| 520-54-218 | In distribution | |
| 508-02-036 | In distribution | |
| 520-50-218 | In distribution | |
| 520-46-318 | In distribution | |
| 530-12-175 | In distribution | |
| 804-38-214 | In distribution | |
| 804-07-120 | In distribution | |
| 804-07-108 | In distribution | |
| 804-07-130 | In distribution | |
| 804-07-167 | In distribution | |
| 530-12-220 | In distribution | |
| 533-06-175 | In distribution | |
| 520-07-254 | In distribution | |
| 530-06-108 | In distribution | |
| 804-07-500 | In distribution | |
| 520-56-322 | In distribution | |
| 521-07-242 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| Humeris Shoulder | Fx Solutions | 69 |
| Prima | Limacorporate | 67 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Recalls Naming This Product
12 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 |
|---|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2023-09-25 | Class II | Labeling Change Control | Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery. | 20 | |
| Encore Medical, L.P. | 510(k) number | 2023-08-04 | Class II | Nonconforming Material/Component | Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery | 15 | |
| Encore Medical, L.P. | 510(k) number | 2021-06-28 | Class II | Process change control | Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery. | ||
| Encore Medical, L.P. | 510(k) number | 2020-08-31 | Class II | Labeling False and Misleading | Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. | 15 | 2024-04-19 |
| Encore Medical, L.P. | 510(k) number | 2018-01-30 | Class II | Device Design | Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial. | 387 units | 2023-05-30 |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 92 units | |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 92 units | |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 92 units | |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 92 units | |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 93 units | |
| Encore Medical, L.P. | 510(k) number | 2015-12-08 | Class II | Nonconforming Material/Component | The trial shell mating feature on the broach is undersized. | 23 units | 2016-03-01 |
| Encore Medical, L.P. | 510(k) number | 2015-09-15 | Class II | Device Design | Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw. | 20 units | 2017-01-10 |
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.