Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MBI · Predicate Candidate Screening
600 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
210 days90th percentile
600clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026-08-03 | 46 | 0 |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-I | Stryker Endoscopy | 2026-07-30 | 20 | 0 |
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026-07-29 | 61 | 0 |
| K261632 | Thunderbolt System | Responsive Arthroscopy, Inc. | 2026-07-20 | 63 | 0 |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knot | Smith & Nephew, Inc. | 2026-07-09 | 28 | 0 |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026-06-26 | 172 | 0 |
| K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 | 244 | 0 |
| K261363 | Y-Knotless™ Flex Anchors | CONMED Corporation | 2026-05-13 | 16 | 0 |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | 2026-05-06 | 229 | 0 |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-05-01 | 254 | 0 |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin Al | Tigon Medical | 2026-04-21 | 33 | 0 |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-20 | 29 | 0 |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026-03-17 | 103 | 0 |
| K254176 | SINEFIX | BAAT Medical Products B.V. | 2026-03-16 | 83 | 0 |
| K251750 | Trax EX Anchor | Trax Surgical, Inc. | 2026-03-12 | 276 | 0 |
| K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | 2026-03-11 | 110 | 0 |
| K260405 | FiberTape Button | Arthrex, Inc. | 2026-03-09 | 28 | 0 |
| K253538 | TeKBrace Knotless Anchor | Theramicro | 2026-03-06 | 113 | 0 |
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | 2026-03-04 | 63 | 0 |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-02 | 63 | 0 |
| K253695 | LigaMend | Riverpoint Medical, LLC | 2026-02-27 | 98 | 0 |
| K253763 | Y-Knotless™ Flex Anchors | Conmed Corporation | 2026-01-29 | 65 | 0 |
| K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 2026-01-28 | 26 | 0 |
| K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | 2026-01-06 | 49 | 0 |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. | 2025-12-30 | 26 | 0 |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | 2025-12-04 | 111 | 0 |
| K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | 2025-11-04 | 74 | 0 |
| K252314 | Arthrex SutureTak Suture Anchor | Arthrex, Inc. | 2025-10-29 | 96 | 0 |
| K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | 2025-10-21 | 29 | 0 |
| K253010 | Mini Superhawk Suture Anchor System | Responsive Arthroscopy, LLC | 2025-10-14 | 25 | 0 |
| K250095 | All-Suture Dual Anchor System | Suturetech, Inc. | 2025-09-05 | 234 | 0 |
| K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | 2025-08-06 | 317 | 0 |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor | Riverpoint Medical | 2025-07-30 | 22 | 0 |
| K251310 | OTS 25-L (100-5) | Ots Medical , Ltd. | 2025-07-22 | 85 | 0 |
| K251809 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2025-07-18 | 36 | 0 |
| K251145 | Arthrex PushLock Suture Anchors | Arthrex, Inc. | 2025-07-10 | 87 | 0 |
| K251933 | SnugFit ASA Extension | Medacta International S.A. | 2025-07-01 | 7 | 0 |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (co | Smith & Nephew, Inc. | 2025-06-25 | 28 | 0 |
| K251530 | CONMED Argo Knotless® Anchor | Conmed Corporation | 2025-06-18 | 30 | 0 |
| K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP | Science & Bio Materials (S.B.M.) Sas | 2025-06-02 | 74 | 0 |
| K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. | 2025-05-12 | 264 | 0 |
| K250596 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2025-03-28 | 28 | 0 |
| K243988 | RootMend MRR | Riverpoint Medical, LLC | 2025-03-20 | 84 | 0 |
| K250424 | Arthrex TightRope Soft Button, RT | Arthrex, Inc. | 2025-03-11 | 25 | 0 |
| K250238 | WasherCap™ Fixation System | Abanza Tecnomed S.L | 2025-02-25 | 29 | 0 |
| K244015 | SuperBall-RC™ | Arcuro Medical , Ltd. | 2025-02-19 | 55 | 0 |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius P | ZheJiang Decans Medical Devices Co., Ltd. | 2025-01-31 | 65 | 0 |
| K243726 | Osprey Suture Anchor | Responsive Arthroscopy, Inc. | 2025-01-30 | 58 | 0 |
| K243712 | WasherCap™ Mini Fixation System (Model 45) | Abanza Tecnomed S.L | 2025-01-30 | 59 | 0 |
| K244025 | Argo Knotless GENESYS Anchor | Conmed Corporation | 2025-01-28 | 32 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda