Arthrex FiberTape and TigerTape Cerclage Sutures
FDA 510(k) K221485 · Arthrex, Inc.
510(k) numberK221485
Submission
- Device name
- Arthrex FiberTape and TigerTape Cerclage Sutures
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- May 23, 2022
- Decision date
- August 22, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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More from Vilex, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | 09/01/2026SE |
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | 08/07/2026SE |
| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | 07/30/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | 06/26/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | 06/25/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | 05/28/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | 03/20/2026SE |
| K260405 | FiberTape ButtonMBI · Special | 03/09/2026SE |
Questions and answers
When was Arthrex FiberTape and TigerTape Cerclage Sutures cleared by the FDA?
Arthrex FiberTape and TigerTape Cerclage Sutures (K221485) received a 510(k) decision of Substantially Equivalent on August 22, 2022, 91 days after the submission was received.
What is the product code of K221485?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.