Biomet Microfixation RibFix Blu Thoracic Fixation System
FDA 510(k) K151173 · Biomet Microfixation
510(k) numberK151173
Submission
- Device name
- Biomet Microfixation RibFix Blu Thoracic Fixation System
- Applicant
- Biomet Microfixation
Jacksonville, FL, US - Received
- May 1, 2015
- Decision date
- May 26, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 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 |
| K212782 | SternaLock Sternal Closure SystemHRS · Traditional | 05/17/2022SE |
| 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 |
Questions and answers
When was Biomet Microfixation RibFix Blu Thoracic Fixation System cleared by the FDA?
Biomet Microfixation RibFix Blu Thoracic Fixation System (K151173) received a 510(k) decision of Substantially Equivalent on May 26, 2015, 25 days after the submission was received.
What is the product code of K151173?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.