SternaLock Sternal Closure System
FDA 510(k) K212782 · Biomet Microfixation
510(k) numberK212782
Submission
- Device name
- SternaLock Sternal Closure System
- Applicant
- Biomet Microfixation
Jacksonville, FL, US - Received
- September 1, 2021
- Decision date
- May 17, 2022
- 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 |
|---|---|---|
| K261002 | Pectus Blu SystemHRS · Traditional | 06/02/2026SE |
| K241709 | Pectus Blu Support Bar SystemHRS · Traditional | 09/19/2024SE |
| K223199 | 2.1 x 255mm Drill, 22mm StopHBE · Special | 11/15/2022SE |
| K212608 | RibFix Blu Thoracic Fixation SystemHRS · Traditional | 04/22/2022SE |
| K213712 | Pectus Support Bar SystemHRS · Traditional | 03/11/2022SE |
| K213208 | Twist DrillsHBE · Traditional | 12/23/2021SE |
| K202969 | Biomet Microfixation OmniMax MMF SystemJEY · Traditional | 08/05/2021SE |
| K190576 | WalterLorenz Surgical Assist Arm Scope HolderOCV · Traditional | 06/05/2019SE |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation SystemHRS · Special | 12/09/2016SE |
| K163007 | Biomet Microfixation SternaLock 360 Sternal Closure SystemHRS · Special | 11/23/2016SE |
Questions and answers
When was SternaLock Sternal Closure System cleared by the FDA?
SternaLock Sternal Closure System (K212782) received a 510(k) decision of Substantially Equivalent on May 17, 2022, 258 days after the submission was received.
What is the product code of K212782?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.