510(k) K262677
- Device
- Iconix Knotless T
- Applicant
- Riverpoint Medical
- 510(k) number
- K262677
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-27
- Date received
- 2026-07-30
- Regulation
- 888.3040
- Classification name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Brice Biggins
- Address
- 825 NE 25th Ave. Portland OR US 97232 97232
FDA Registration Numbers#
- 3011061237
- 3021393544
- 3027978412
- 1017294
- 3024021261
- 3025608439
- 3002579136
- 3021226419
- 3012494290
- 3007093114
- 3011580264
- 3015216945
- 2936485
- 3010047454
- 2649614
- 3009971621
- 3015539532
- 3007109793
- 3015542154
- 3002808227
- 2020550
- 3017196117
- 3016948539
- 3014262693
- 3013176080
- 3043861298
- 3010531069
- 1835572
- 8043734
- 2648623
- 3004142400
- 3014680795
- 3032314868
- 3013767421
- 2245304
- 1220246
- 3030514683
- 3009227834
- 1835251
- 3004549189
- 1834379
- 1834331
- 1061927
- 1043534
- 1220477
- 1222928
- 1225492
- 3006498370
- 3025318945
- 3000270450
- 8043971
- 3006946276
- 3005941719
- 2024311
- 3004365956
- 1058584
- 3014273424
- 2648666
- 2183946
- 1319660
- 3020899789
- 3012818475
- 3020704423
- 1054811
- 3011530718
- 3010202439
- 3048284429
- 3015231789
- 3022393834
- 1835444
- 3014315560
- 3006809628
- 3010863450
- 2032098
- 3006017180
- 3006742481
- 3008262872
- 3008650117
- 3007420745
- 3011683674
Source Documents#
Other 510(k) Records For Product Code MBI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026-08-03 |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy | 2026-07-30 |
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026-07-29 |
| K261632 | Thunderbolt System | Responsive Arthroscopy, Inc. | 2026-07-20 |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | 2026-07-09 |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026-06-26 |
| K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| K261363 | Y-Knotless™ Flex Anchors | CONMED Corporation | 2026-05-13 |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | 2026-05-06 |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-05-01 |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | 2026-04-21 |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-20 |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026-03-17 |
| K254176 | SINEFIX | BAAT Medical Products B.V. | 2026-03-16 |
| K251750 | Trax EX Anchor | Trax Surgical, Inc. | 2026-03-12 |