Parcus Knotless AP Suture Anchors
FDA 510(k) K192824 · Parcus Medical, LLC
510(k) numberK192824
Submission
- Device name
- Parcus Knotless AP Suture Anchors
- Applicant
- Parcus Medical, LLC
Sarasota, FL, US - Received
- October 2, 2019
- Decision date
- November 2, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
| K260294 | SF Push-in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 03/27/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
| K251680 | Biosteon® ScrewMAI · Traditional | Biocomposites, Ltd. | 02/17/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
More from Stryker Endoscopy
| 510(k) | Device | Decision |
|---|---|---|
| K232513 | X-Twist Biocomposite Suture AnchorMAI · Special | 09/18/2023SE |
| K221502 | Parcus Synd-EZ SSMBI · Traditional | 07/26/2022SE |
| K221135 | X-Twist PEEK Suture AnchorMBI · Special | 05/19/2022SE |
| K212739 | ActiFlipMBI · Traditional | 10/06/2021SE |
| K202662 | Parcus Titanium Interference ScrewsMBI · Traditional | 02/22/2021SE |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…MBI · Traditional | 10/28/2020SE |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsMBI · Traditional | 07/23/2020SE |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorMBI · Special | 01/23/2020SE |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipMBI · Traditional | 01/16/2020SE |
| K192964 | Parcus Synd-EZ SSMBI · Special | 11/22/2019SE |
Questions and answers
When was Parcus Knotless AP Suture Anchors cleared by the FDA?
Parcus Knotless AP Suture Anchors (K192824) received a 510(k) decision of Substantially Equivalent on November 2, 2019, 31 days after the submission was received.
What is the product code of K192824?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.