CITRESPLINE and CITRELOCK ACL Implants
FDA 510(k) K210239 · Acuitive Technologies, Inc.
510(k) numberK210239
Submission
- Device name
- CITRESPLINE and CITRELOCK ACL Implants
- Applicant
- Acuitive Technologies, Inc.
Alendale, NJ, US - Received
- January 29, 2021
- Decision date
- February 24, 2021
- 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
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|---|---|---|---|
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K240450 | CitreporeMQV · Traditional | 11/06/2024SE |
| K232592 | Citrelock® DuoMBI · Special | 09/20/2023SE |
| K221468 | Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device…MAI · Traditional | 02/14/2023SE |
| K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock…MAI · Traditional | 11/04/2022SE |
| K203334 | The Citrefix Knotless Suture AnchorMAI · Traditional | 02/05/2021SE |
| K200725 | Citregen Tendon Interference Screw and CitrelockMAI · Traditional | 10/07/2020SE |
Questions and answers
When was CITRESPLINE and CITRELOCK ACL Implants cleared by the FDA?
CITRESPLINE and CITRELOCK ACL Implants (K210239) received a 510(k) decision of Substantially Equivalent on February 24, 2021, 26 days after the submission was received.
What is the product code of K210239?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.