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

OWY · Predicate Candidate Screening

14 FDA 510(k) clearances under this product code; the 50 most recent screened below.

130 daysmedian FDA review time

266 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K251690	Arthrex SpeedFLEX™ Implant	Arthrex, Inc.	2025-09-30	120
K252647	Tapestry Biointegrative Implant	Embody, Inc.	2025-09-19	29
K250109	TYBR Collagen Gel	Tybr Health	2025-06-06	141
K243843	Tendon Protect (50242)	Kerecis Limited	2025-06-04	173
K242631	REGENETEN™ Bioinductive Implant	Smith & Nephew Inc., Endoscopy Div.	2024-11-26	84
K222501	Regeneten Bioinductive Implant	Smith and Nephew, Inc.	2023-05-11	266
K220867	Tapestry Biointegrative Implant	Embody, Inc.	2022-05-23	59
K212306	Tapestry Biointegrative Implant	Embody, Inc.	2021-11-02	102
K201572	TAPESTRY Biointegrative Implant	Embody, Inc.	2020-10-19	130
K151083	BioBridge Collagen Matrix	Fibralign Corporation	2016-01-08	261
K140300	COLLAGEN TENDON SHEET-DDI (CTS-DDI)	Rotation Medical, Inc.	2014-03-26	48
K133169	MESO TENDON MATRIX	Kensey Nash Corporation Dba Dsm Biomedical	2013-12-20	64
K131143	TRELLIS COLLAGEN RIBBON	Wrightmedicaltechnologyinc	2013-10-07	167
K120479	MTF FASCIA	Musculoskeletal Transplant Foundation	2012-11-08	266

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