Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Arthrex, Inc. — Predicate Candidate Screening

352 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time

231 days90th percentile

352clearances measured

K-number	Device	Applicant	Decided	Review days
K262357	Arthrex Bioabsorbable PushLock Suture Anchors	Arthrex, Inc.	2026-08-07	28
K260624	Arthrex Radial Head Replacement System	Arthrex, Inc.	2026-07-30	154
K260018	Arthrex FiberButton	Arthrex, Inc.	2026-06-26	172
K260809	Arthrex Sterile VAL and VAL KreuLock™ Compression Screw Syst	Arthrex, Inc.	2026-06-25	105
K253931	Arthrex Bioabsorbable PushLock Suture Anchors	Arthrex, Inc.	2026-05-28	170
K254215	Arthrex Beaming System	Arthrex, Inc.	2026-05-08	130
K252016	Arthrex Humeral Nails	Arthrex, Inc.	2026-03-20	266
K260561	Arthrex FiberTak Suture Anchor	Arthrex, Inc.	2026-03-20	29
K260405	FiberTape Button	Arthrex, Inc.	2026-03-09	28
K252196	Arthrex FibuLock Nail System	Arthrex, Inc.	2026-03-05	234
K260353	Arthrex Humeral Plating System (Anatomic Humeral Plate) and	Arthrex, Inc.	2026-03-03	28
K254229	Arthrex Nano FiberTak Suture Anchor	Arthrex, Inc.	2026-03-02	63
K253713	Arthrex Variable Angle (VA) Proximal Tibia Plating System	Arthrex, Inc.	2026-01-21	58
K252807	Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates	Arthrex, Inc.	2026-01-12	131
K253895	Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm	Arthrex, Inc.	2025-12-30	26
K253727	Syndesmosis TightRope PRO	Arthrex, Inc.	2025-12-22	28
K252314	Arthrex SutureTak Suture Anchor	Arthrex, Inc.	2025-10-29	96
K251994	Arthrex Synergy Vision Imaging System	Arthrex, Inc.	2025-10-16	111
K251690	Arthrex SpeedFLEX™ Implant	Arthrex, Inc.	2025-09-30	120
K251809	Arthrex FiberTak Suture Anchor	Arthrex, Inc.	2025-07-18	36
K251145	Arthrex PushLock Suture Anchors	Arthrex, Inc.	2025-07-10	87
K251453	Arthrex iBalance Partial Knee System	Arthrex, Inc.	2025-07-01	50
K243480	SuturePatch Tissue Reinforcement	Arthrex, Inc.	2025-05-29	202
K250920	Arthrex Spine Compression FT Screw	Arthrex, Inc.	2025-05-22	56
K243602	Arthrex Spine Endoscope	Arthrex, Inc.	2025-05-16	176
K250728	Arthrex Synergy Vision Endoscopic Imaging System	Arthrex, Inc.	2025-05-05	55
K250596	Arthrex FiberTak Suture Anchor	Arthrex, Inc.	2025-03-28	28
K243995	Arthrex Humeral Plating System and Cerclage Button	Arthrex, Inc.	2025-03-26	90
K250526	Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anch	Arthrex, Inc.	2025-03-14	18
K250424	Arthrex TightRope Soft Button, RT	Arthrex, Inc.	2025-03-11	25
K243344	Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Ra	Arthrex, Inc.	2025-02-20	118
K243742	Arthrex DynaNite Nitinol Staples	Arthrex, Inc.	2025-01-31	58
K243008	Arthrex NanoScope System	Arthrex, Inc.	2025-01-22	118
K243890	Arthrex Intramedullary Nails	Arthrex, Inc.	2025-01-13	26
K243195	Arthrex SS VAL and VAL KreuLock™ Compression Screw System	Arthrex, Inc.	2025-01-10	101
K242079	Arthrex Elbow Fracture Plating System	Arthrex, Inc.	2024-11-14	121
K242554	Arthrex VAL and VAL KreuLock™ Compression Screw System	Arthrex, Inc.	2024-10-21	55
K241097	Arthrex Virtual Implant Positioning (VIP) System Software	Arthrex, Inc.	2024-10-02	163
K241592	Arthrex VAL and VAL KreuLock™ Compression Screw System	Arthrex, Inc.	2024-08-31	89
K241361	Arthrex Synergy Vision Endoscopic Imaging System	Arthrex, Inc.	2024-07-25	72
K240815	Arthrex Cannulated Screw System	Arthrex, Inc.	2024-06-13	80
K233971	Arthrex AlloSync PushLock Suture Anchor	Arthrex, Inc.	2024-06-04	172
K241235	Arthrex TightRope II	Arthrex, Inc.	2024-05-29	27
K233260	Univers Revers CA Head and Adapter	Arthrex, Inc.	2024-02-12	136
K233451	Arthrex Synergy Vision Endoscopic Imaging System	Arthrex, Inc.	2024-01-18	90
K232973	Arthrex Knee FiberTak® Button Suture Anchor	Arthrex, Inc.	2023-11-15	55
K232742	Arthrex FiberTak Suture Anchor	Arthrex, Inc.	2023-11-03	57
K232897	Arthrex Small External Fixation System	Arthrex, Inc.	2023-10-18	30
K232755	Arthrex FiberTape and TigerTape Cerclage Sutures	Arthrex, Inc.	2023-10-06	28
K230513	Arthrex Univers Apex OptiFit Humeral Stem	Arthrex, Inc.	2023-09-26	214

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