KLS Martin IPS Forearm System
FDA 510(k) K250865 · KLS-Martin L.P.
510(k) numberK250865
Submission
- Device name
- KLS Martin IPS Forearm System
- Applicant
- KLS-Martin L.P.
Jacksonville, FL, US - Received
- March 21, 2025
- Decision date
- November 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | 08/17/2026SE |
| K254162 | KLS Martin Ixos SystemHRS · Traditional | 02/20/2026SE |
| K253660 | KLS Martin Pure Pectus SystemHRS · Traditional | 02/20/2026SE |
| K250988 | KLS Martin Pure Pectus SystemHRS · Traditional | 12/11/2025SE |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional | 11/10/2025SE |
| K250620 | KLS Martin Ixos SystemHRS · Traditional | 08/15/2025SE |
| K233721 | KLS Martin Drill-Free MMF ScrewDZL · Traditional | 09/17/2024SE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional | 08/16/2024SE |
| K241018 | KLS Martin Orthopedic Implants - MR ConditionalHRS · Traditional | 07/12/2024SE |
| K230211 | CranioXpandPBJ · Traditional | 11/21/2023SE |
Questions and answers
When was KLS Martin IPS Forearm System cleared by the FDA?
KLS Martin IPS Forearm System (K250865) received a 510(k) decision of Substantially Equivalent on November 14, 2025, 238 days after the submission was received.
What is the product code of K250865?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.