Biomet OrthoPak Non-Invasive Bone Growth Stimulator System
Orthopak Stimulator, Biomet
1manufacturer
6catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
Record
| Listed by | EBI, LLC, United States |
|---|---|
| FDA product code | LOF |
| Device type | Stimulator, Bone Growth, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5870 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | P850022 |
| Record published | 2019-02-28 |
| Record revised | 2025-05-23 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 122 °F; Storage environment humidity 10 to 90 % RH; Special storage condition: Keep Dry; Storage environment atmospheric pressure 50 to 100 KiloPascal |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1067718-45 | In distribution | |
| 1067719 | In distribution | |
| 1067718 | In distribution | |
| 1067718-72 | In distribution | |
| 1067718-63 | In distribution | |
| 1067727 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pemf – Physio-Stim | Orthofix US LLC | 39 |
| Physio-Stim | Orthofix US LLC | 26 |
| Biomet EBI Bone Healing System | EBI, LLC | 24 |
| Biomet SpinalPak / OrthoPak | EBI, LLC | 18 |
| Orthofix Osteogenesis Stimulator | Orthofix US LLC | 16 |
| Xstim | Xstim Inc. | 11 |
| ActaStim-S | Theragen, Inc. | 11 |
| CMF | DJO, LLC | 8 |
| Biomet SpinalPak Non-invasive Spine Fusion Stimulator System | EBI, LLC | 7 |
| Cervical-Stim | Orthofix US LLC | 7 |
| Accelstim | Igea SPA | 6 |
| Spinal Stim | Orthofix US LLC | 6 |
Showing 12 of 21. All products under Stimulator, Bone Growth, Non-Invasive
Recalls
4 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 |
|---|---|---|---|---|
| 2024-03-22 | Class II | Device Design | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment | |
| 2024-03-22 | Class II | Device Design | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment | 1412 units ( 2 leads per assembly) |
| 2024-03-22 | Class II | Device Design | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment | 829 units (2 lead wires assembly) |
| 2024-03-22 | Class II | Device Design | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment | 594 units (2 lead wires assembly) |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P210016 | 2025-01-17 | ManaFuse | Enovis |
| P230025 | 2024-11-12 | Xstim Spine Fusion Stimulator | Xstim Inc. |
| P790002 | 2022-11-23 | Biomet® OrthoPak Non-invasive Bone Growth Stimulator System | Ahp Eos Buyer, Inc. |
| P190030 | 2022-06-17 | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. |
| P210035 | 2022-05-03 | AccelStimTM Bone Growth Stimulator | Orthofix US LLC |
| P850007 | 2018-08-22 | PhysioStim, SpinalStim | Orthofix SRL |
| P900009 | 2017-09-11 | EXOGEN Ultrasound Bone Healing System | Bioventus LLC |
| P850022 | 2015-09-09 | BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR | Ahp Eos Buyer, Inc. |
| P030034 | 2009-09-11 | CERVICAL-STIM | Orthofix SRL |
| P910066 | 1997-01-03 | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR | DJO, LLC |
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.