510(k) · Cleared
ClearedSportmesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artimplant AB · FTL Mesh, Surgical, Polymeric
Cleared on Jan 19, 2006 as substantially equivalent to K042809 (Organogenesis, Inc., 2004) and 3 other predicates after a 106-day review. Its family tree reaches back 7 generations to 1992. 44 later devices descend from it.
- Decided
- Jan 19, 2006
- Review
- 106 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K921895 (1992). 29 ancestors in all, the oldest K830889 (1983). 44 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 4 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 3 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 2 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 1 generation backK042809 CuffpatchOrganogenesis, Inc. · 2004
- This deviceK052830 SportmeshArtimplant AB · 2006
- Descendant · cites it directly · 28 of its ownK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- Descendant · cites it directly · 17 of its ownK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- Descendant · 2 generations on · 11 of its ownK072370 Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008
- Descendant · 2 generations on · 9 of its ownK192112 FlexBand PlusInternational Life Sciences · 2019
- Descendant · cites it directly · 9 of its ownK083307 Synthasome X-RepairSynthasome, Inc. · 2009
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007 · cites it directly28descendants
- K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008 · cites it directly17descendants
- K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008 · 2 generations on11descendants
- K192112FlexBand PlusInternational Life Sciences · 2019 · 2 generations on9descendants
- K083307Synthasome X-RepairSynthasome, Inc. · 2009 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −6 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −4 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −3 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −1 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| 0 (this device) | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| +1 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| +1 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| +2 | K072370 | Surgicraft Surgical Mesh System | Surgicraft, Ltd. | 2008 | — |
| +2 | K192112 | FlexBand Plus | International Life Sciences | 2019 | — |
| +1 | K083307 | Synthasome X-Repair | Synthasome, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042809 | CuffpatchSummary page 1…Product Code: FTM 2. Equivalent devices SportrneShTM is substantially equivalent to: Organogenesis, Inc's FortaFleXTM Surgical Mesh (K042809) DePuy, Inc's Restore® Orthobiologic Soft Tissue Implant (K(031969,1(001738) Etdieon, Inc's ULTRAPROrmMesh… | 2004 |
| * | K031969 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…is substantially equivalent to: Organogenesis, Inc's FortaFleXTM Surgical Mesh (K042809) DePuy, Inc's Restore® Orthobiologic Soft Tissue Implant (K(031969,1(001738) Etdieon, Inc's ULTRAPROrmMesh (033337) Davol 's NMarlex Mesh (pre-Amendimcnts) 3. Descri… | 2003 |
| * | K001738 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…ntially equivalent to: Organogenesis, Inc's FortaFleXTM Surgical Mesh (K042809) DePuy, Inc's Restore® Orthobiologic Soft Tissue Implant (K(031969,1(001738) Etdieon, Inc's ULTRAPROrmMesh (033337) Davol 's NMarlex Mesh (pre-Amendimcnts) 3. Description of… | 2000 |
| * | K033337 | Ultrapro MeshSummary page 1…nc's FortaFleXTM Surgical Mesh (K042809) DePuy, Inc's Restore® Orthobiologic Soft Tissue Implant (K(031969,1(001738) Etdieon, Inc's ULTRAPROrmMesh (033337) Davol 's NMarlex Mesh (pre-Amendimcnts) 3. Description of the Device SportmneShrliS a knitted fab… | 2004 |
| Kept off the family tree | K020256 | FDA’s K020256 is Unicem Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
| * | — | Marlex Mesh Named without a submission number |
What descends from it? (44)
See all 446 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 14 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K071887 (Artimplant AB, 2007) has gone furthest, with 28 descendants of its own.
- 5 other devices also cite its predicate K042809.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
SportmeshTM is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. SportmeshTM is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.
SportmeshTM is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. SportmeshTM reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052830: Sportmesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052830
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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