510(k) · Cleared
ClearedBiomerix Surgical Mesh, Model: RCR-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerix Corporation · FTL Mesh, Surgical, Polymeric
Cleared on Feb 25, 2008 as substantially equivalent to K031969 (DePuy Orthopaedics, Inc., 2003) and 3 other predicates after a 326-day review. Its family tree reaches back 8 generations to 1992. 17 later devices descend from it.
- Decided
- Feb 25, 2008
- Review
- 326 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K921895 (1992). 48 ancestors in all, the oldest K830889 (1983). 17 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 4 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 3 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 2 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 1 generation backK052830 SportmeshArtimplant AB · 2006
- This deviceK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- Descendant · cites it directly · 11 of its ownK072370 Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008
- Descendant · 2 generations on · 7 of its ownK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- Descendant · 3 generations on · 5 of its ownK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- Descendant · 4 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · cites it directly · 3 of its ownK082941 Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation · 2009
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008 · cites it directly11descendants
- K090288Orthadapt PRPegasus Biologics, Inc. · 2009 · 2 generations on7descendants
- K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011 · 3 generations on5descendants
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 4 generations on4descendants
- K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation · 2009 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −4 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −2 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −1 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| 0 (this device) | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| +1 | K072370 | Surgicraft Surgical Mesh System | Surgicraft, Ltd. | 2008 | — |
| +2 | K090288 | Orthadapt PR | Pegasus Biologics, Inc. | 2009 | — |
| +3 | K112786 | Proseries Bioimplants-Proankle/Procuff | Synovis Orthopedic and Woundcare, Inc. | 2011 | — |
| +4 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +1 | K082941 | Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215 | Biomerix Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031969 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…meric surgical mesh Classification Name: Mesh, surgical, polymeric Predicate Devices: DePuy Restore® Orthobiologic Soft Tissue Implant, K031 969 Artimplant AB SportmeshTM (K052830) Ethicon Mersilene Polyester Fiber Mesh (pre-… | 2003 |
| * | K052830 | SportmeshSummary page 1…polymeric Predicate Devices: DePuy Restore® Orthobiologic Soft Tissue Implant, K031 969 Artimplant AB SportmeshTM (K052830) Ethicon Mersilene Polyester Fiber Mesh (pre- amendment)… | 2006 |
| * | K053562 | Zimmer Collagen Repair PatchSummary page 1…M (K052830) Ethicon Mersilene Polyester Fiber Mesh (pre- amendment) Zimmer Collagen Repair Patch (K053562) Biomnerix Vascular Occlusion Device (K043371) Device Description: The Biomerix Surgical Mesh is a no… | 2006 |
| * | K043371 | Biomerix Vascular Occlusion Device and LoaderSummary page 1…Mesh (pre- amendment) Zimmer Collagen Repair Patch (K053562) Biomnerix Vascular Occlusion Device (K043371) Device Description: The Biomerix Surgical Mesh is a non-absorbable mesh manufactured from a polycarb… | 2005 |
| * | — | Ethicon Mersilene Polyester Fiber Mesh Named without a submission number |
What descends from it? (17)
See all 174 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 48 ancestors have a recall of any class.
- Of its descendants, K072370 (Surgicraft, Ltd., 2008) has gone furthest, with 11 descendants of its own.
- 7 other devices also cite its predicate K031969.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery.
The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070961: Biomerix Surgical Mesh, Model: RCR-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070961
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026