Polarus Connect
FDA 510(k) K131636 · Acumed, LLC
510(k) numberK131636
Submission
- Device name
- Polarus Connect
- Applicant
- Acumed, LLC
Hillsboro, OR, US - Received
- June 4, 2013
- Decision date
- October 10, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LXT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230067 | Para-Fix External Fixation SystemLXT · Traditional | New Paradigm Biomedical | 09/22/2023SE |
| K132704 | Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowLXT · Traditional | Biomet | 10/09/2013SE |
| K112345 | Distal Volar Radius Plating SystemsLXT · Traditional | Medos International SARL | 10/31/2011SE |
| K090374 | Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…LXT · Special | DePuy Orthopaedics, Inc. | 03/11/2009SE |
| K073135 | Synthes (USA) Hybrid External Fixator ModificationsLXT · Traditional | Synthes (Usa) | 01/29/2008SE |
| K063832 | Synthes (USA) Elbow Hinge FixatorLXT · Traditional | Synthes (Usa) | 03/07/2007SE |
| K060864 | Multidirectional Threaded PegLXT · Special | Hand Innovations, LLC | 04/28/2006SE |
| K060403 | Pta (Progressive Tibial Alignment)LXT · Traditional | Meridian Medical | 03/28/2006SE |
| K060290 | Shoulder Fixation SystemLXT · Special | Hand Innovations, LLC | 02/27/2006SE |
| K052754 | Wrist Fusion PlateLXT · Traditional | Dvo Extremity Solutions, LLC | 10/27/2005SE |
More from Dvo Extremity Solutions, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm ScrewsHRS · Special | 08/21/2025SE |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsHRS · Abbreviated | 07/14/2025SE |
| K251296 | The Acumed Wrist Fixation SystemHRS · Traditional | 06/18/2025SE |
| K243624 | Acu-Sinch Knotless MiniHTN · Traditional | 01/23/2025SE |
| K233311 | Acumed Wrist Plating SystemHRS · Traditional | 04/22/2024SE |
| K230744 | Acumed Acutrak 3 Headless Compression Screw SystemHWC · Traditional | 06/09/2023SE |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalHWC · Traditional | 12/29/2022SE |
| K212990 | Acumed Ankle Syndesmosis Repair SystemHTN · Traditional | 01/07/2022SE |
| K210750 | Acumed Clavicle Hook Plating SystemHRS · Traditional | 07/15/2021SE |
| K151886 | Acumed Ankle and Small Fragment Base Set UpdateHRS · Traditional | 10/30/2015SE |
Questions and answers
When was Polarus Connect cleared by the FDA?
Polarus Connect (K131636) received a 510(k) decision of Substantially Equivalent on October 10, 2013, 128 days after the submission was received.
What is the product code of K131636?
The FDA product code is LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, a Class II (moderate risk) device regulated under 21 CFR 888.3030.