Responsive Arthroscopy Interference Screw System
FDA 510(k) K202569 · Responsive Arthroscopy, LLC
510(k) numberK202569
Submission
- Device name
- Responsive Arthroscopy Interference Screw System
- Applicant
- Responsive Arthroscopy, LLC
Minneapolis, MN, US - Received
- September 4, 2020
- Decision date
- September 23, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261632 | Thunderbolt SystemMBI · Special | 07/20/2026SE |
| K253010 | Mini Superhawk Suture Anchor SystemMBI · Special | 10/14/2025SE |
| K243726 | Osprey Suture AnchorMBI · Traditional | 01/30/2025SE |
| K233258 | Shadow Knotless All-Suture AnchorsMBI · Special | 10/23/2023SE |
| K230094 | Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsMBI · Traditional | 08/25/2023SE |
| K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsMBI · Special | 10/13/2022SE |
| K203121 | Responsive Arthroscopy Thunderbolt SystemMBI · Traditional | 04/27/2021SE |
| K202153 | Responsive Arthroscopy Suture Anchor SystemMBI · Special | 09/09/2020SE |
| K190446 | Responsive Arthroscopy Wedge Push-In Suture AnchorsMBI · Special | 03/27/2019SE |
| K181076 | Responsive Arthroscopy Wedge Push-In Suture AnchorsMBI · Traditional | 01/18/2019SE |
Questions and answers
When was Responsive Arthroscopy Interference Screw System cleared by the FDA?
Responsive Arthroscopy Interference Screw System (K202569) received a 510(k) decision of Substantially Equivalent on September 23, 2020, 19 days after the submission was received.
What is the product code of K202569?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.