INVISIKNOT Ankle Syndesmosis Repair Kit
FDA 510(k) K162996 · Smith & Nephew, Inc.
510(k) numberK162996
Submission
- Device name
- INVISIKNOT Ankle Syndesmosis Repair Kit
- Applicant
- Smith & Nephew, Inc.
Andover, MA, US - Received
- October 27, 2016
- Decision date
- June 8, 2017
- 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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| K253115 | Lars AcjHTN · Traditional | Movmedix S.A.S. | 06/10/2026SE |
| K252081 | SportLinc Syndesmosis DeviceHTN · Traditional | Lincotek Medical | 03/27/2026SE |
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| K242091 | Bolo Button SystemHTN · Traditional | Fusion Orthopedics | 12/23/2024SE |
| K243408 | TACTIX Vector Syndesmosis SystemHTN · Special | Vilex, LLC | 11/27/2024SE |
| K242311 | EXPERT - Flexible Joint Fixation SystemHTN · Traditional | GM Dos Reis Industria e Comercio Ltda. | 11/01/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | Vilex, LLC | 08/01/2024SE |
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| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
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Questions and answers
When was INVISIKNOT Ankle Syndesmosis Repair Kit cleared by the FDA?
INVISIKNOT Ankle Syndesmosis Repair Kit (K162996) received a 510(k) decision of Substantially Equivalent on June 8, 2017, 224 days after the submission was received.
What is the product code of K162996?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.