A.L.P.S. Small Fragment Plating System
FDA 510(k) K243761 · Biomet Orthopedics
510(k) numberK243761
Submission
- Device name
- A.L.P.S. Small Fragment Plating System
- Applicant
- Biomet Orthopedics
Warsaw, IN, US - Received
- December 6, 2024
- Decision date
- February 19, 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 |
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| 510(k) | Device | Decision |
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| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | 04/15/2026SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | 07/12/2023SE |
| K200196 | Taperloc® Complete Hip StemsLZO · Traditional | 12/08/2020SE |
| K131393 | Mak Oss Femoral Knee ComponentsKRO · Traditional | 10/24/2013SE |
| K112905 | Compress(R) Segmental Humeral Replacement SystemMBF · Traditional | 05/24/2012SE |
| K080528 | E-Poly Tibial BearingsJWH · Traditional | 06/17/2008SE |
| K072879 | Innervue Diagnostic Scope SystemHRX · Traditional | 01/14/2008SE |
| K070955 | Acid Etched Lag ScrewsHSB · Traditional | 10/12/2007SE |
| K033355 | Lactoscrew Screw AnchorHWC · Traditional | 06/30/2004SE |
Questions and answers
When was A.L.P.S. Small Fragment Plating System cleared by the FDA?
A.L.P.S. Small Fragment Plating System (K243761) received a 510(k) decision of Substantially Equivalent on February 19, 2025, 75 days after the submission was received.
What is the product code of K243761?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.