Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FTM — Predicate Candidate Screening
163 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
239 days90th percentile
163clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250598 | Endoform Reconstructive Template - PLGA | Aroa Biosurgery , Ltd. | 2025-06-03 | 95 | 0 |
| K243595 | OviTex PRS (Long-Term Resorbable) | TELA Bio, Inc. | 2024-12-19 | 29 | 0 |
| K233991 | CanGaroo RM Antibacterial Envelope | Elutia, Inc. | 2024-06-14 | 179 | 0 |
| K241126 | OviTex PRS | TELA Bio, Inc. | 2024-05-22 | 29 | 0 |
| K223052 | Peri-Guard and Supple Peri-Guard | Synovis Life Technologies, Inc. | 2023-04-07 | 190 | 4 |
| K214070 | OviTex PRS (Long Term Resorbable) | Tela Bio | 2023-03-21 | 449 | 0 |
| K213163 | VersaWrap | Alafair Biosciences, Inc. | 2021-10-29 | 31 | 0 |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Colla | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | 2021-10-27 | 30 | 0 |
| K203496 | Nexo-Gide Bilayer Collagen Membrane | Geistlich Pharma AG | 2021-07-14 | 229 | 0 |
| K203600 | VersaWrap | Alafair Biosciences, Inc. | 2021-03-09 | 90 | 0 |
| K192452 | Lyograft | B. Bruan Surgical, SA | 2020-09-03 | 360 | 0 |
| K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2020-07-13 | 88 | 0 |
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGa | Aziyo Biologics, Inc. | 2020-06-15 | 28 | 0 |
| K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2020-03-06 | 29 | 0 |
| K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Gri | Synovis Life Technologies, Inc. (Baxter International Inc.) | 2019-12-17 | 85 | 0 |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGa | Aziyo Biologics, Inc. | 2019-10-21 | 28 | 0 |
| K182493 | Bovine Pericardial Tissue Patch | Tisgenx | 2019-06-18 | 280 | 0 |
| K183398 | Endoform Restella | Aroa Biosurgery , Ltd. | 2019-04-11 | 125 | 0 |
| K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wire | Synthes (USA) Products, LLC | 2019-03-13 | 89 | 0 |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | Acell, Inc. | 2019-02-07 | 170 | 0 |
| K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (m | Aziyo Biologics, Inc. | 2018-11-15 | 87 | 0 |
| K171817 | Biodesign Diaphragmatic Hernia Graft | Cook Biotech Incorporated | 2018-03-13 | 267 | 0 |
| K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGa | Aziyo Biologics, Inc. | 2017-10-25 | 19 | 0 |
| K172937 | Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC | 2017-10-25 | 29 | 0 |
| K162934 | Biodesign Parastomal Hernia Repair Graft | Cook Biotech Incorporated | 2017-07-10 | 263 | 0 |
| K170016 | Biodesign Fistula Plug | Cook Biotech Incorporated | 2017-06-21 | 169 | 0 |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Exten | Acell, Inc. | 2017-06-08 | 87 | 0 |
| K162752 | ARTIA Reconstructive Tissue Matrix Perforated | Lifecell Corporation | 2017-02-24 | 147 | 0 |
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | Tei Biosciences, Inc. | 2017-02-16 | 115 | 1 |
| K162570 | Miromatrix Biological Mesh TW | Miromatrix Medical, Inc. | 2017-02-16 | 154 | 0 |
| K162388 | CuraSeal Percutaneous Intraluminal Closure System for Anorec | Curaseal, Inc. | 2017-02-03 | 162 | 0 |
| K162461 | Endoform Plastics and Reconstructive Matrix | Aroa Biosurgery (Formerly Mesynthes Limited) | 2016-12-20 | 109 | 0 |
| K162554 | Gentrix Surgical Matrix | Acell, Inc. | 2016-10-21 | 38 | 0 |
| K160181 | COLORADO THERAPEUTICS XENOGRAFT IMPLANT | Colorado Therapeutics, LLC | 2016-10-20 | 267 | 0 |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign | Cook Biotech Incorporated | 2016-05-26 | 27 | 0 |
| K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Pey | Cook Biotech Incorporated | 2016-04-29 | 30 | 1 |
| K153633 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | 2016-03-15 | 88 | 0 |
| K152206 | SurgiPure XD Reconstructive Tissue Matrix | Tissue Regenix Group Plc | 2016-03-08 | 215 | 0 |
| K150668 | Biodesign Enterocutaneous Fistula Plug | Cook Biotech Incorprated | 2015-12-09 | 268 | 0 |
| K142887 | SIS Inguinal Hernia Repair Graft | Cook Biotech Incorprated | 2015-10-01 | 364 | 0 |
| K150712 | LTM-Perforated Surgical Mesh | Lifecell Corporation | 2015-07-02 | 105 | 0 |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Flo | Acell, Inc. | 2015-06-17 | 415 | 0 |
| K142326 | HP Tissue Matrix | Lifecell Corporation | 2014-12-23 | 125 | 0 |
| K141721 | BOVINE PERICARDIUM PATCH | Collafirm, LLC | 2014-12-22 | 180 | 0 |
| K141053 | OVINE TISSUE MATRIX(OTM) | TELA Bio, Inc. | 2014-12-11 | 231 | 0 |
| K142070 | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS | Rti Surgical, Inc. | 2014-10-27 | 89 | 0 |
| K140306 | CORMATRIX PROTECT ECM ENVELOPE | Cormatrix Cardiovascular, Inc. | 2014-08-15 | 189 | 0 |
| K133306 | SIS HERNIA GRAFT | Cook Biotech, Inc. | 2014-07-23 | 268 | 0 |
| K140501 | XENMATRIX SURGICAL GRAFT | C. R. Bard | 2014-04-28 | 60 | 0 |
| K134033 | MIROMATRIX BIOLOGICAL MESH | Miromatrix Medical, Inc. | 2014-03-31 | 90 | 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