Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809
FDA 510(k) K103831 · Depuy Mitek, A Johnson & Johnson Company
510(k) numberK103831
Submission
- Device name
- Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
Raynham, MA, US - Received
- December 30, 2010
- Decision date
- July 21, 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 |
|---|---|---|
| K143660 | Milagro / Milagro Advance Interference ScrewMAI · Traditional | 05/21/2015SE |
| K142574 | 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…MBI · Special | 10/24/2014SE |
| K140896 | Vapr Arctic Suction ElectrodeGEI · Traditional | 08/05/2014SE |
| K141259 | Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon PEEK…MAI · Special | 06/10/2014SE |
| K133794 | 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…MAI · Traditional | 02/04/2014SE |
| K132241 | Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…MAI · Traditional | 11/05/2013SE |
| K130814 | Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMMBI · Traditional | 08/01/2013SE |
| K131974 | Healix Advance Knotless BR Anchor (6.5MM)MAI · Special | 07/25/2013SE |
| K131191 | 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur PLUS/4MM Barrel Tornado Bur Plus…HRX · Traditional | 07/22/2013SE |
| K130912 | Omnicut Resection BladeHRX · Traditional | 06/14/2013SE |
Questions and answers
When was Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809 cleared by the FDA?
Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809 (K103831) received a 510(k) decision of Substantially Equivalent on July 21, 2011, 203 days after the submission was received.
What is the product code of K103831?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.