Nonresorbable Centraloc Tibial Screw & Washer
FDA 510(k) K051069 · Arthrotek, Inc.
510(k) numberK051069
Submission
- Device name
- Nonresorbable Centraloc Tibial Screw & Washer
- Applicant
- Arthrotek, Inc.
Warsaw, IN, US - Received
- April 26, 2005
- Decision date
- June 29, 2005
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K061776 | Arthrotek Maxfire Meniscal Repair DeviceJDR · Traditional | 09/25/2006SE |
| K061801 | 2.8 & 3.5MM Lactoscrew Suture AnchorsJDR · Traditional | 08/07/2006SE |
| K061657 | Hitch Lactosorb Suture AnchorJDR · Traditional | 07/25/2006SE |
| K061389 | Allthread Lactosorb Suture AnchorJDR · Traditional | 07/19/2006SE |
| K060693 | Microstrike and Allthread PEEK Suture AnchorHWC · Traditional | 06/06/2006SE |
| K053461 | Ezloc Femoral Fixation DeviceMBI · Traditional | 02/03/2006SE |
| K042460 | Ti - Screw Anchor SPMBI · Traditional | 10/29/2004SE |
| K041274 | Resorbable Interference ScrewHWC · Traditional | 07/28/2004SE |
| K041261 | Femoral HookMBI · Special | 06/07/2004SE |
| K040604 | Innervue Diagnostic Scope SystemGCJ · Traditional | 06/04/2004SE |
Questions and answers
When was Nonresorbable Centraloc Tibial Screw & Washer cleared by the FDA?
Nonresorbable Centraloc Tibial Screw & Washer (K051069) received a 510(k) decision of Substantially Equivalent on June 29, 2005, 64 days after the submission was received.
What is the product code of K051069?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.