Osteoraptor Curved 2.3 Suture Anchors
FDA 510(k) K103309 · Smith & Nephew Endoscopy, Inc.
510(k) numberK103309
Submission
- Device name
- Osteoraptor Curved 2.3 Suture Anchors
- Applicant
- Smith & Nephew Endoscopy, Inc.
Andover, MA, US - Received
- November 10, 2010
- Decision date
- February 3, 2011
- 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 |
|---|---|---|
| K102660 | Bioraptor Curved 2.3 PK Suture AnchorsMBI · Traditional | 12/13/2010SE |
| K093428 | Smith & Nephew Knotless Instability AnchorMBI · Traditional | 12/17/2009SE |
| K083635 | Smith & Nephew Biosure PK Interference ScrewMBI · Traditional | 01/30/2009SE |
| K083226 | Smith & Nephew PEEK Interference ScrewMBI · Traditional | 01/30/2009SE |
| K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair DeviceHTN · Traditional | 10/21/2008SE |
| K050580 | Smith & Nephew Intelijet Fluid Management SystemsHRX · Traditional | 04/20/2005SE |
| K992396 | Biorci ScrewHWC · Traditional | 01/12/2000SE |
| K991500 | Smith & Nephew Suture LokOCW · Traditional | 07/14/1999SE |
| K972599 | Acufex Screw CannulaHWC · Traditional | 09/19/1997SE |
| K971939 | Smith & Nephew Suture ColletOCW · Traditional | 08/06/1997SE |
Questions and answers
When was Osteoraptor Curved 2.3 Suture Anchors cleared by the FDA?
Osteoraptor Curved 2.3 Suture Anchors (K103309) received a 510(k) decision of Substantially Equivalent on February 3, 2011, 85 days after the submission was received.
What is the product code of K103309?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.