DJO Surgical
RSP Monoblock Socket Insert, 32MM +4MM, Semiconstrained, HXE-Plus
9manufacturers in China registered for this device type
109catalogue numbers in this listing
16510(k) clearances naming this product code
14recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (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 |
|---|---|---|---|---|
| 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 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K172351 |
| Record published | 2017-12-13 |
| Record revised | 2024-06-28 (version 6) |
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 |
|---|---|---|
| 509-02-444 | In distribution | |
| 508-36-101 | In distribution | |
| 509-01-432 | In distribution | |
| 533-06-220 | In distribution | |
| 804-06-316 | In distribution | |
| 509-01-440 | In distribution | |
| 506-02-132 | In distribution | |
| 509-01-436 | In distribution | |
| 509-03-032 | In distribution | |
| 509-02-440 | In distribution | |
| 506-03-118 | In distribution | |
| 508-80-040 | In distribution | |
| 508-40-101 | In distribution | |
| 804-06-312 | In distribution | |
| 506-04-130 | In distribution | |
| 533-08-108 | In distribution | |
| 508-01-432 | In distribution | |
| 507-12-175 | In distribution | |
| 506-04-122 | In distribution | |
| 507-08-175 | In distribution | |
| 508-01-040 | In distribution | |
| 508-40-103 | In distribution | |
| 508-07-000 | In distribution | |
| 508-32-105 | In distribution | |
| 506-00-008 | In distribution | |
| 506-00-006 | In distribution | |
| 509-01-032 | In distribution | |
| 508-03-440 | In distribution | |
| 509-00-032 | In distribution | |
| 804-06-412 | In distribution | |
| 508-00-036 | In distribution | |
| 508-01-436 | In distribution | |
| 804-06-406 | In distribution | |
| 508-32-104 | In distribution | |
| 506-02-126 | In distribution | |
| 506-02-134 | In distribution | |
| 507-10-175 | In distribution | |
| 506-02-128 | In distribution | |
| 530-12-108 | In distribution | |
| 506-00-007 | In distribution | |
| 506-03-138 | In distribution | |
| 508-00-004 | In distribution | |
| 506-03-114 | In distribution | |
| 506-05-030 | In distribution | |
| 506-02-124 | In distribution | |
| 509-01-036 | In distribution | |
| 508-80-030 | In distribution | |
| 804-06-404 | In distribution | |
| 508-00-008 | In distribution | |
| 509-01-040 | In distribution | |
| 508-01-440 | In distribution | |
| 506-05-022 | In distribution | |
| 506-06-000 | In distribution | |
| 804-06-405 | In distribution | |
| 533-08-220 | In distribution | |
| 804-06-323 | In distribution | |
| 506-02-130 | In distribution | |
| 804-06-409 | In distribution | |
| 508-03-040 | In distribution | |
| 506-02-116 | In distribution | |
| 804-06-328 | In distribution | |
| 804-06-401 | In distribution | |
| 508-02-032 | In distribution | |
| 506-03-130 | In distribution | |
| 508-65-040 | In distribution | |
| 508-01-032 | In distribution | |
| 506-00-012 | In distribution | |
| 507-06-175 | In distribution | |
| 508-01-036 | In distribution | |
| 804-06-349 | In distribution | |
| 804-06-308 | In distribution | |
| 509-00-040 | In distribution | |
| 804-06-337 | In distribution | |
| 804-06-311 | In distribution | |
| 506-02-114 | In distribution | |
| 804-06-309 | In distribution | |
| 508-32-103 | In distribution | |
| 508-00-040 | In distribution | |
| 804-06-330 | In distribution | |
| 506-03-126 | In distribution | |
| 804-06-402 | In distribution | |
| 506-05-014 | In distribution | |
| 804-06-408 | In distribution | |
| 804-06-407 | In distribution | |
| 508-36-103 | In distribution | |
| 506-04-118 | In distribution | |
| 506-02-138 | In distribution | |
| 506-02-118 | In distribution | |
| 506-04-114 | In distribution | |
| 508-00-032 | In distribution | |
| 506-03-134 | In distribution | |
| 530-14-108 | In distribution | |
| 533-10-175 | In distribution | |
| 506-02-136 | In distribution | |
| 508-00-001 | In distribution | |
| 508-02-436 | In distribution | |
| 506-02-120 | In distribution | |
| 804-06-306 | In distribution | |
| 508-00-000 | In distribution | |
| 509-00-036 | In distribution | |
| 508-80-000 | In distribution | |
| 533-12-000 | In distribution | |
| 506-00-010 | In distribution | |
| 533-08-000 | In distribution | |
| 506-03-122 | In distribution | |
| 506-02-122 | In distribution | |
| 509-02-036 | In distribution | |
| 508-65-001 | In distribution | |
| 508-32-101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| FX V135 | Fx Shoulder Solutions SAS | 131 |
| Prima TT Glenoid | Limacorporate | 129 |
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 124 |
| Equinoxe | Exactech, Inc. | 123 |
| Veritas rTSA | restor3d, inc. | 112 |
| R1 Reverse Shoulder System | Catalyst Orthoscience Inc | 100 |
| Tornier Perform™ Humeral System | Tornier Inc. | 96 |
| MSS – Monobloc stem | Medacta International SA | 92 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
| Perform™ Humeral System | Tornier Inc. | 74 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252567 | 2026-01-15 |
| K252141 | 2025-08-05 |
| K251184 | 2025-05-16 |
| K233481 | 2024-05-29 |
| K173073 | 2017-12-26 |
| K141990 | 2014-11-07 |
| K140904 | 2014-05-06 |
| K130550 | 2014-03-24 |
| K112069 | 2011-11-15 |
| K111735 | 2011-10-03 |
| K111629 | 2011-09-16 |
| K111061 | 2011-07-20 |
| K103208 | 2011-01-31 |
| K100741 | 2010-08-02 |
| K051075 | 2005-05-27 |
| K041066 | 2005-03-24 |
Recalls Naming This Product
18 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 | 2026-01-15 | Class II | Process control | Knee and Humeral socket implants contain incorrect labeling. | 20 implants | |
| Encore Medical, L.P. | 510(k) number | 2025-07-18 | Class II | Device Design | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | 927 units | |
| Encore Medical, L.P. | 510(k) number | 2025-07-18 | Class II | Device Design | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | 907 units | |
| Encore Medical, L.P. | 510(k) number | 2025-07-18 | Class II | Device Design | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | 447 units | |
| Encore Medical, L.P. | 510(k) number | 2025-05-28 | Class II | Process control | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. | 400 units | |
| Encore Medical, L.P. | 510(k) number | 2025-05-28 | Class II | Process control | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. | 200 units | |
| Encore Medical, L.P. | 510(k) number | 2025-05-28 | Class II | Process control | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. | 36 units | |
| Encore Medical, L.P. | 510(k) number | 2025-05-28 | Class II | Process control | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. | 200 units | |
| Encore Medical, L.P. | 510(k) number | 2023-10-05 | Class II | Packaging process control | Mislabeling | 17 units | |
| 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 | 2023-09-25 | 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 | 2023-08-22 | Class II | Mixed-up of materials/components | Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation. | 70 | |
| 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 | 64 | |
| 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 | 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 | 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 |
Recalls
2 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 |
|---|---|---|---|---|
| 2023-10-05 | Class II | Packaging process control | Mislabeling | 2 units |
| 2023-09-06 | Class II | Component design/selection | Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver | 146 units |
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.