Arthrosurface Kissloc Knotless Suture System
FDA 510(k) K133835 · Arthrosurface, Inc.
510(k) numberK133835
Submission
- Device name
- Arthrosurface Kissloc Knotless Suture System
- Applicant
- Arthrosurface, Inc.
Franklin, MA, US - Received
- December 18, 2013
- Decision date
- July 3, 2014
- 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
Other 510(k)s with product code HTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253115 | Lars AcjHTN · Traditional | Movmedix S.A.S. | 06/10/2026SE |
| K252081 | SportLinc Syndesmosis DeviceHTN · Traditional | Lincotek Medical | 03/27/2026SE |
| K253727 | Syndesmosis TightRope PROHTN · Special | Arthrex, Inc. | 12/22/2025SE |
| K251643 | Synchfix EVTHTN · Traditional | Wright Medical Technology, Inc. (Stryker… | 10/29/2025SE |
| K251134 | RipCordHTN · Traditional | TriMed, Inc. | 07/11/2025SE |
| K243624 | Acu-Sinch Knotless MiniHTN · Traditional | Acumed, LLC | 01/23/2025SE |
| 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 |
More from Vilex, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty SystemPHX · Traditional | 06/24/2021SE |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty SystemJWJ · Traditional | 10/15/2020SE |
| K190261 | BOSS Toe Fixation SystemKWD · Traditional | 08/14/2019SE |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty SystemKRR · Special | 06/14/2018SE |
| K173964 | OVOMotion Shoulder Arthroplasty SystemHSD · Traditional | 04/18/2018SE |
| K172383 | Arthrosurface Bone ScrewsHWC · Traditional | 12/22/2017SE |
| K170440 | KISSloc Suture SystemHTN · Traditional | 05/03/2017SE |
| K170350 | ToeMATE® Hammertoe Correction SystemHWC · Special | 03/03/2017SE |
| K162391 | AlignMATE Lapidus Arthrodesis SystemHRS · Special | 02/21/2017SE |
| K161539 | Arthrosurface Bone ScrewsHWC · Special | 06/30/2016SE |
Questions and answers
When was Arthrosurface Kissloc Knotless Suture System cleared by the FDA?
Arthrosurface Kissloc Knotless Suture System (K133835) received a 510(k) decision of Substantially Equivalent on July 3, 2014, 197 days after the submission was received.
What is the product code of K133835?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.