Unity Beta Plla System
FDA 510(k) K090175 · Bonutti Research, Inc.
510(k) numberK090175
Submission
- Device name
- Unity Beta Plla System
- Applicant
- Bonutti Research, Inc.
Effingham, IL, US - Received
- January 23, 2009
- Decision date
- September 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K161628 | JAS Pulse(TM) Ultrasonic TherapyIMI · Abbreviated | 11/10/2016SE |
| K093078 | Unity Ultrasonic System with Plla AnchorsHWC · Special | 06/23/2010SE |
| K082906 | Unity Beta Anchor SystemHWC · Special | 10/30/2008SE |
| K062820 | Unity Alpha SystemHWC · Traditional | 03/15/2007SE |
| K060283 | Transet SystemHTY · Special | 02/22/2006SE |
| K052799 | Multitak 6.0 MM Absorbable Anchor SystemMAI · Traditional | 12/16/2005SE |
| K033717 | Transet Fracture Fixation SystemHTY · Traditional | 02/25/2004SE |
| K013177 | Multitak Suture Snap SystemGAM · Traditional | 12/19/2001SE |
| K012465 | Multitak Splinter 3.0 MM Resorbable AnchorMAI · Traditional | 10/29/2001SE |
| K010479 | Multitak Conical Tip Bone Soft Tissue Suture AnchorHTY · Traditional | 05/08/2001SE |
Questions and answers
When was Unity Beta Plla System cleared by the FDA?
Unity Beta Plla System (K090175) received a 510(k) decision of Substantially Equivalent on September 10, 2009, 230 days after the submission was received.
What is the product code of K090175?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.