510(k) K241010
- Device
- HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
- Applicant
- Depuy Mitek
- 510(k) number
- K241010
- Product code
- MAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-11
- Date received
- 2024-04-12
- Regulation
- 888.3030
- Classification name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Lidia Moses
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers
- 1450662
- 3005180920
- 3006498370
- 3021226419
- 3005536892
- 1649390
- 3013176080
- 3001592626
- 3016727307
- 2031917
- 3014252644
- 3015453963
- 2183946
- 1834331
- 1018470
- 3014560508
- 3015806723
- 3002579136
- 3012818475
- 1643264
- 3007193505
- 9610612
- 2246552
- 1319660
- 1721676
- 3015718210
- 3010162973
- 1226183
- 3038284030
- 3027339877
- 2024024
- 9615788
- 3017196117
- 8010177
- 1225798
- 3003139373
- 3014262693
- 3010331645
- 3030655570
- 3008110533
- 3015539532
- 3020704423
- 3022472578
- 3015231789
- 3002907620
- 9710629
- 2530154
- 3008793310
- 3014279513
- 3038503932
- 3007648354
- 9681465
- 1058584
- 3007842664
- 3015173212
- 3010400367
- 1226146
- 3002807310
- 3006638824
- 3012470322
- 2936485
- 2032830
- 2183967
- 3016948539
- 8031010
- 3011230048
- 3009732568
- 3007319107
- 3011430871
- 1526534
- 3006981798
- 3015780293
- 3014004349
- 3008812560
- 3003755939
- 1061927
- 3004549189
- 3025318945
- 3015724777
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code MAI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | 2026-03-27 |
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2026-02-24 |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | 2026-02-17 |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025-10-15 |
| K252022 | OSSIOfiber® Interference Screw | OSSIO , Ltd. | 2025-08-19 |
| K251309 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2025-05-27 |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy | 2025-05-23 |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite Anchor | Stryker Endoscopy | 2025-05-21 |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. | 2025-04-03 |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | Arthrex, Inc. | 2025-03-14 |
| K243790 | GRYPHON X Anchor; HEALIX TRANSTEND Anchor | Depuy Mitek | 2025-02-05 |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | 2024-12-03 |
| K241912 | BIOCHARGE | Nanofiber Solutions, LLC | 2024-07-29 |
| K233971 | Arthrex AlloSync PushLock Suture Anchor | Arthrex, Inc. | 2024-06-04 |
| K240288 | SF Push- in Anchor | Surgical Fusion Technologies GmbH | 2024-04-01 |