Inion Anchron Biodegradable Anchor System, Model ANC-6000
FDA 510(k) K051362 · Inion OY
510(k) numberK051362
Submission
- Device name
- Inion Anchron Biodegradable Anchor System, Model ANC-6000
- Applicant
- Inion OY
Tampere, FI - Received
- May 25, 2005
- Decision date
- August 4, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional | 11/07/2025SE |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…HBW · Traditional | 07/11/2025SE |
| K203105 | Inion CompressOn ScrewHWC · Traditional | 01/13/2021SE |
| K191764 | Inion BioRestoreMQV · Special | 07/31/2019SE |
| K151360 | Inion Spinal Graft Containment SystemOJB · Traditional | 10/06/2015SESU |
| K133932 | Inion FreedompinHTY · Traditional | 04/11/2014SE |
| K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)HWC · Traditional | 02/27/2013SE |
| K122890 | Inion CPS Orbital PlatesJEY · Traditional | 01/29/2013SE |
| K090177 | Inion Biorestore Biodegradable Bone Graft SubstituteMQV · Special | 02/20/2009SE |
| K071810 | Inion Spinal Graft Containment SystemOJB · Traditional | 07/11/2008SESU |
Questions and answers
When was Inion Anchron Biodegradable Anchor System, Model ANC-6000 cleared by the FDA?
Inion Anchron Biodegradable Anchor System, Model ANC-6000 (K051362) received a 510(k) decision of Substantially Equivalent on August 4, 2005, 71 days after the submission was received.
What is the product code of K051362?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.