510(k) K263348
- Device
- Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINIT
- Applicant
- Smith & Nephew, Inc.
- 510(k) number
- K263348
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-23
- Date received
- 2026-09-23
- 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
- Dongeun LoPresti
- Address
- 150 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 3033273526
- 3005064037
- 3012818475
- 3018094310
- 3008868758
- 3011580264
- 3002579136
- 8043792
- 3014302784
- 3021008900
- 3032412536
- 3007319107
- 3017034897
- 1835572
- 3016926753
- 3008837339
- 3008262872
- 3008749819
- 1000484830
- 3010047402
- 3005381997
- 3019807891
- 3030514683
- 2244478
- 3025141
- 3007993775
- 3005180920
- 3032314868
- 3013302242
- 3006946276
- 3010060157
- 3013767421
- 3016727307
- 3006742481
- 2530154
- 3009826895
- 3006108336
- 3006981798
- 2090040
- 3021632375
- 3003139373
- 3030412764
- 3008114965
- 3015216945
- 3015151147
- 3003477135
- 3015806723
- 3004976965
- 9613350
- 1313525
- 3008812560
- 3006017180
- 3012329552
- 3017528621
- 2936485
- 3015718210
- 2246552
- 3015200759
- 3016676864
- 3006563559
- 3010400367
- 3021226419
- 3010667733
- 3015131017
- 1320894
- 3021336182
- 3000203391
- 8020712
- 3011230048
- 3024021261
- 3011295718
- 3011989923
- 3010375065
- 2031093
- 2648666
- 3006990600
- 3007193505
- 3016678045
- 3013756169
- 1417592
Source Documents#
Other 510(k) Records For Product Code MBI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263352 | TeKBrace Knotless Anchor | TheraMicro | 2026-10-21 |
| K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | 2026-09-17 |
| K253065 | Aevumed SUPERCYNCH™ Button System | Aevumed, Inc. | 2026-09-02 |
| K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-09-02 |
| K262677 | Iconix Knotless T | Riverpoint Medical | 2026-08-27 |
| 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 |