Model 3000 Axyaloop Bio-Absorbable Bone Anchor
FDA 510(k) K051983 · Axya Medical, Inc.
510(k) numberK051983
Submission
- Device name
- Model 3000 Axyaloop Bio-Absorbable Bone Anchor
- Applicant
- Axya Medical, Inc.
Beverly, MA, US - Received
- July 22, 2005
- Decision date
- August 5, 2005
- 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 |
|---|---|---|
| K070773 | Axya, Model 3000 Axyzloop Titanium Bone AnchorMBI · Traditional | 10/11/2007SE |
| K070253 | Axya Suture Welding System and KitGAT · Traditional | 07/11/2007SE |
| K063194 | Tufflex Polyester SutureGAT · Special | 12/04/2006SE |
| K060165 | Axyaflex Polyester SutureGAT · Traditional | 09/01/2006SE |
| K060970 | Axyaloop Nonabsorbable Bone AnchorJDR · Traditional | 07/05/2006SE |
| K052491 | Axya Model 6500 Axyaloop Self-Tapping Bone AnchorMBI · Special | 10/07/2005SE |
| K051250 | Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorMAI · Special | 06/09/2005SE |
| K041698 | Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorMAI · Traditional | 10/05/2004SE |
| K022207 | Axya Model 3000 Axyaloop Titanium Bone Anchor SystemMBI · Traditional | 10/04/2002SE |
| K021929 | Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical SystemLFL · Traditional | 09/10/2002SE |
Questions and answers
When was Model 3000 Axyaloop Bio-Absorbable Bone Anchor cleared by the FDA?
Model 3000 Axyaloop Bio-Absorbable Bone Anchor (K051983) received a 510(k) decision of Substantially Equivalent on August 5, 2005, 14 days after the submission was received.
What is the product code of K051983?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.