Peba Anchor/Suture Combination
FDA 510(k) K972326 · Orthopaedic Biosystems, Ltd.
510(k) numberK972326
Submission
- Device name
- Peba Anchor/Suture Combination
- Applicant
- Orthopaedic Biosystems, Ltd.
Scotsdale, AZ, US - Received
- June 23, 1997
- Decision date
- February 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262809 | ArthroTAK Tendon Anchor KitMBI · Special | ArthroTAK, LLC | 09/02/2026SE |
| K253065 | Aevumed SUPERCYNCH Button SystemMBI · Traditional | Aevumed, Inc. | 09/02/2026SE |
| K262677 | Iconix Knotless TMBI · Special | Riverpoint Medical | 08/27/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | Paragon 28, Inc. | 08/03/2026SE |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | Stryker Endoscopy | 07/30/2026SE |
| K261770 | Suture Button Repair SystemMBI · Traditional | Skeletal Dynamics, Inc. | 07/29/2026SE |
| K261632 | Thunderbolt SystemMBI · Special | Responsive Arthroscopy, Inc. | 07/20/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | Smith & Nephew, Inc. | 07/09/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | Arthrex, Inc. | 06/26/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K000797 | Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01JDR · Special | 04/03/2000SE |
| K982996 | Polymer Obl SB Anchor / Suture CombinationJDR · Traditional | 03/04/1999SE |
| K983169 | Polymer Threaded AnchorMBI · Traditional | 12/16/1998SE |
| K982963 | Polymer Threaded Anchor / Suture CombinationJDI · Traditional | 11/20/1998SE |
| K963420 | Cancellous Screw WasherHTN · Traditional | 11/15/1996SE |
| K963432 | Guide Wires for Cannulated ScrewsLXT · Traditional | 11/13/1996SE |
| K963433 | Threaded Fixation PinJDW · Traditional | 11/06/1996SE |
| K962779 | Compression ScrewHWC · Traditional | 08/23/1996SN |
| K951451 | Peba Anchor (Multiple Sizes)MBI · Traditional | 10/31/1995SN |
| K942889 | SB AnchorJDR · Traditional | 08/25/1995SE |
Questions and answers
When was Peba Anchor/Suture Combination cleared by the FDA?
Peba Anchor/Suture Combination (K972326) received a 510(k) decision of Substantially Equivalent on February 6, 1998, 228 days after the submission was received.
What is the product code of K972326?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.