DJO Surgical
HXL/FMP Acetabular Trial Liner, NON-Hooded, 36MM/76MM Multi Hole
26manufacturers in China registered for this device type
2,141catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
Showing 12 of 26. All 26 manufacturers in China registered for Guide, Surgical, Instrument
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | FZX |
| Device type | Guide, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K160342 |
| Record published | 2017-08-07 |
| Record revised | 2023-05-15 (version 15) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 801-01-442 | In distribution | |
| 800-05-050 | In distribution | |
| 801-05-871 | In distribution | |
| 801-05-849 | In distribution | |
| 801-05-406 | In distribution | |
| 803-51-443 | In distribution | |
| 800-01-242 | In distribution | |
| 801-03-017 | In distribution | |
| 800-01-227 | In distribution | |
| 801-01-387 | In distribution | |
| 803-00-020 | In distribution | |
| 803-05-237 | In distribution | |
| 801-01-396 | In distribution | |
| 803-99-054 | In distribution | |
| 803-00-145 | In distribution | |
| 803-04-076 | In distribution | |
| 804-02-066 | In distribution | |
| 801-01-616 | In distribution | |
| 801-01-580 | In distribution | |
| 803-15-323 | In distribution | |
| 800-01-452 | In distribution | |
| 342-12-705 | In distribution | |
| 800-03-002 | In distribution | |
| 800-02-358 | In distribution | |
| 804-00-100 | In distribution | |
| 803-00-118 | In distribution | |
| 801-05-824 | In distribution | |
| 800-01-323 | In distribution | |
| 800-01-093 | In distribution | |
| 800-01-316 | In distribution | |
| 800-01-412 | In distribution | |
| 801-01-740 | In distribution | |
| 803-42-40K | In distribution | |
| 803-44-44J | In distribution | |
| 803-44-44I | In distribution | |
| 800-99-021 | In distribution | |
| 801-01-312 | In distribution | |
| 801-01-290 | In distribution | |
| 341-16-702 | In distribution | |
| 801-05-888 | In distribution | |
| 803-42-32E | In distribution | |
| 801-01-293 | In distribution | |
| 800-99-053 | In distribution | |
| 803-85-436 | In distribution | |
| 803-05-117 | In distribution | |
| 801-05-317 | In distribution | |
| 801-05-881 | In distribution | |
| 803-55-442 | In distribution | |
| 803-08-025 | In distribution | |
| 800-05-414 | In distribution | |
| 800-01-251 | In distribution | |
| 804-02-073 | In distribution | |
| 803-08-018 | In distribution | |
| 803-32-012 | In distribution | |
| 803-20-060 | In distribution | |
| 803-05-149 | In distribution | |
| 801-05-042 | In distribution | |
| 801-05-892 | In distribution | |
| 803-52-361 | In distribution | |
| S-201244 | In distribution | |
| 801-01-336 | In distribution | |
| 801-04-069 | In distribution | |
| 800-01-348 | In distribution | |
| 800-04-068 | In distribution | |
| 800-03-003 | In distribution | |
| 341-14-708 | In distribution | |
| 803-95-065 | In distribution | |
| 800-01-090 | In distribution | |
| 803-04-118 | In distribution | |
| 801-01-285 | In distribution | |
| 803-84-332 | In distribution | |
| 341-14-706 | In distribution | |
| 803-84-328 | In distribution | |
| 801-04-133 | In distribution | |
| 801-01-377 | In distribution | |
| 341-12-707 | In distribution | |
| 803-41-28C | In distribution | |
| 803-43-40J | In distribution | |
| 804-50-018 | In distribution | |
| 800-05-409 | In distribution | |
| 800-01-195 | In distribution | |
| 803-43-40I | In distribution | |
| 800-01-240 | In distribution | |
| 800-04-044 | In distribution | |
| 318-02-004 | In distribution | |
| 801-01-736 | In distribution | |
| 800-99-049 | In distribution | |
| 803-43-32C | In distribution | |
| 803-03-056 | In distribution | |
| 803-05-156 | In distribution | |
| 800-01-211 | In distribution | |
| 241-02-110 | In distribution | |
| 317-02-004 | In distribution | |
| 803-55-363 | In distribution | |
| 800-01-347 | In distribution | |
| 801-05-412 | In distribution | |
| 804-46-116 | In distribution | |
| 801-05-325 | In distribution | |
| 801-05-875 | In distribution | |
| 803-04-040 | In distribution | |
| 803-02-013 | In distribution | |
| 800-01-442 | In distribution | |
| 803-53-366 | In distribution | |
| 801-05-449 | In distribution | |
| 803-08-023 | In distribution | |
| 804-50-118 | In distribution | |
| 801-01-639 | In distribution | |
| 804-02-076 | In distribution | |
| 801-06-003 | In distribution | |
| 803-52-363 | In distribution | |
| 801-05-675 | In distribution | |
| 803-15-362 | In distribution | |
| 803-41-28B | In distribution | |
| 351-02-103 | In distribution | |
| 804-02-462 | In distribution | |
| 800-05-059 | In distribution | |
| 351-02-109 | In distribution | |
| S-201817 | In distribution | |
| 804-02-465 | In distribution | |
| 801-01-161 | In distribution | |
| 801-05-546 | In distribution | |
| 342-19-703 | In distribution | |
| 414842 | In distribution | |
| 803-05-033 | In distribution | |
| 801-05-313 | In distribution | |
| 803-05-043 | In distribution | |
| 800-01-269 | In distribution | |
| 800-02-320 | In distribution | |
| S-201788 | In distribution | |
| 800-01-280 | In distribution | |
| 801-01-619 | In distribution | |
| 801-05-535 | In distribution | |
| 414936 | In distribution | |
| 803-02-026 | In distribution | |
| 801-03-031 | In distribution | |
| 804-00-107 | In distribution | |
| 804-03-057 | In distribution | |
| 803-95-175 | In distribution | |
| 801-05-643 | In distribution | |
| 351-03-102 | In distribution | |
| 801-01-214 | In distribution | |
| 802-01-056 | In distribution | |
| 804-06-033 | In distribution | |
| 803-52-282 | In distribution | |
| 800-04-069 | In distribution | |
| 804-06-038 | In distribution | |
| 801-01-428 | In distribution | |
| 804-06-205 | In distribution | |
| 414845 | In distribution | |
| 803-00-100 | In distribution | |
| 801-04-071 | In distribution | |
| 341-10-706 | In distribution | |
| 801-05-423 | In distribution | |
| 800-05-312 | In distribution | |
| 414871 | In distribution | |
| 803-86-240 | In distribution | |
| 801-05-547 | In distribution | |
| 803-55-443 | In distribution | |
| 801-05-609 | In distribution | |
| 803-95-285 | In distribution | |
| 803-43-44I | In distribution | |
| 801-05-560 | In distribution | |
| 801-01-390 | In distribution | |
| 800-01-357 | In distribution | |
| 803-42-44K | In distribution | |
| 803-44-40J | In distribution | |
| 803-54-369 | In distribution | |
| 801-02-015 | In distribution | |
| 800-99-131 | In distribution | |
| 801-01-221 | In distribution | |
| 801-01-327 | In distribution | |
| 800-05-422 | In distribution | |
| 801-05-634 | In distribution | |
| 803-03-052 | In distribution | |
| 317-02-010 | In distribution | |
| 803-05-159 | In distribution | |
| 803-53-367 | In distribution | |
| 801-05-410 | In distribution | |
| 342-12-710 | In distribution | |
| 800-05-069 | In distribution | |
| 801-01-283 | In distribution | |
| 804-38-018 | In distribution | |
| 800-01-273 | In distribution | |
| 801-05-647 | In distribution | |
| 801-05-484 | In distribution | |
| 801-04-130 | In distribution | |
| 804-02-464 | In distribution | |
| 801-05-321 | In distribution | |
| 803-52-369 | In distribution | |
| 414881 | In distribution | |
| 803-08-036 | In distribution | |
| 803-05-153 | In distribution | |
| 800-05-075 | In distribution | |
| 801-05-445 | In distribution | |
| 801-05-440 | In distribution | |
| 804-54-126 | In distribution | |
| 801-01-388 | In distribution | |
| 801-01-158 | In distribution | |
| 801-05-653 | In distribution | |
| 801-05-336 | In distribution | |
| 414875 | In distribution | |
| 241-01-107 | In distribution | |
| 801-05-821 | In distribution | |
| 803-54-401 | In distribution | |
| S-201793 | In distribution | |
| 801-01-252 | In distribution | |
| 800-99-098 | In distribution | |
| 801-01-423 | In distribution | |
| 804-38-014 | In distribution | |
| 801-05-645 | In distribution | |
| 801-01-632 | In distribution | |
| 803-04-079 | In distribution | |
| 800-01-233 | In distribution | |
| 800-01-314 | In distribution | |
| 801-04-166 | In distribution | |
| 317-02-006 | In distribution | |
| 803-20-049 | In distribution | |
| 803-15-014 | In distribution | |
| S-201668 | In distribution | |
| 803-53-369 | In distribution | |
| 342-14-707 | In distribution | |
| 801-05-607 | In distribution | |
| 803-20-053 | In distribution | |
| 800-99-132 | In distribution | |
| 803-43-36E | In distribution | |
| 804-25-110 | In distribution | |
| 351-01-106 | In distribution | |
| 800-99-062 | In distribution | |
| 801-05-658 | In distribution | |
| 800-01-417 | In distribution | |
| 801-05-498 | In distribution | |
| 801-05-355 | In distribution | |
| 241-01-110 | In distribution | |
| 351-04-106 | In distribution | |
| 803-10-105 | In distribution | |
| 801-05-212 | In distribution | |
| 801-01-409 | In distribution | |
| 803-52-362 | In distribution | |
| 801-03-021 | In distribution | |
| 801-05-437 | In distribution | |
| 800-05-416 | In distribution | |
| 803-86-428 | In distribution | |
| 801-05-426 | In distribution | |
| 801-05-035 | In distribution | |
| 803-00-045 | In distribution | |
| 801-05-663 | In distribution | |
| 800-03-007 | In distribution | |
| 803-05-161 | In distribution | |
| 804-00-105 | In distribution | |
| 800-05-420 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Guide, Surgical, Instrument | Synthes Gmbh | 727 |
| DJO Surgical | DJO, LLC | 284 |
| Apex Knee System | Omni Life Science, Inc. | 272 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 223 |
| Motoband CP | Crossroads Extremity Systems LLC | 221 |
| Advance® | Microport Orthopedics Inc. | 199 |
| NexGen® | Zimmer, Inc. | 194 |
| Evolution® | Microport Orthopedics Inc. | 173 |
| Innomed, Inc. | Innomed, Inc. | 172 |
| Newclip Instruments | Newclip Technics SAS | 144 |
| Guide, Surgical, Instrument | Zimmer, Inc. | 135 |
| Natural Knee® | Zimmer, Inc. | 134 |
Showing 12 of 1,788. All products under Guide, Surgical, Instrument
Recalls Naming This Product
10 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 |
|---|---|---|---|---|---|---|
| Encore Medical, L.P. | UDI-DI | 2026-02-16 | Class II | Process change control | Due to packaging discrepancy with incorrect product size mixed up. | 4 |
| Encore Medical, L.P. | UDI-DI | 2026-02-16 | Class II | Process change control | Due to packaging discrepancy with incorrect product size mixed up. | 8 |
| Encore Medical, L.P. | UDI-DI | 2026-01-15 | Class II | Process control | Knee and Humeral socket implants contain incorrect labeling. | 14 implants |
| Encore Medical, L.P. | UDI-DI | 2026-01-05 | Class II | Labeling Change Control | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices o | 19 |
| Encore Medical, L.P. | UDI-DI | 2025-07-09 | Class II | Labeling Change Control | Knee implants contain incorrect labeling (size and/or side incorrect) | 18 implants |
| Encore Medical, L.P. | UDI-DI | 2025-07-09 | Class II | Labeling Change Control | Knee implants contain incorrect labeling (size and/or side incorrect) | 40 implants |
| Encore Medical, L.P. | UDI-DI | 2025-06-02 | Class II | Packaging change control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. | 20 |
| Encore Medical, L.P. | UDI-DI | 2025-06-02 | Class II | Packaging change control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. | 20 |
| Encore Medical, L.P. | UDI-DI | 2023-08-22 | Class II | Labeling Change Control | Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee) | 36 |
| Encore Medical, L.P. | 510(k) number | 2022-12-22 | Class II | Labeling Change Control | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the in | 216 |
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.