510(k) · Cleared
ClearedTornier Collagen Coated Biofiber Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jan 25, 2012 as substantially equivalent to K070894 (Tepha, Inc., 2007) and 4 other predicates after a 258-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Jan 25, 2012
- Review
- 258 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K921895 (1992). 66 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations between
- 3 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 2 generations backK093799 Tornier Surgical MeshTornier, Inc. · 2010
- 1 generation backK102788 Tornier Biofiber ScaffoldTornier, Inc. · 2011
- This deviceK111337 Tornier Collagen Coated Biofiber ScaffoldTornier, Inc. · 2012
Show all 11 generations
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 5 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 4 generations backK052830 SportmeshArtimplant AB · 2006
- 3 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 2 generations backK093799 Tornier Surgical MeshTornier, Inc. · 2010
- 1 generation backK102788 Tornier Biofiber ScaffoldTornier, Inc. · 2011
- This deviceK111337 Tornier Collagen Coated Biofiber ScaffoldTornier, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −10 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −8 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −7 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −5 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −4 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −3 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| −2 | K093799 | Tornier Surgical Mesh | Tornier, Inc. | 2010 | — |
| −1 | K102788 | Tornier Biofiber Scaffold | Tornier, Inc. | 2011 | — |
| 0 (this device) | K111337 | Tornier Collagen Coated Biofiber Scaffold | Tornier, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 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 |
|---|---|---|---|
| * | K070894 | Tephaflex Surgical MeshSummary page 1…Product code: FTL - Class 11 Predicate Devices Tepha, Inc., Inc. TephaFLEXI h Surgical Mesh [510(k) Number K070894] Tornier, Inc. Tornier® BioFiberTM Scaffold - (Surgical Mesh) [510O(k) K1 02788 and K0… | 2007 |
| * | K102788 | Tornier Biofiber ScaffoldSummary page 1…Mesh [510(k) Number K070894] Tornier, Inc. Tornier® BioFiberTM Scaffold - (Surgical Mesh) [510O(k) K1 02788 and K093799] Sofradim Production PREVADH Th ' Surgical Mesh (Covidien) [510(k) K073287] Artimplant AB… | 2011 |
| * | K093799 | Tornier Surgical MeshSummary page 1…[510(k) Number K070894] Tornier, Inc. Tornier® BioFiberTM Scaffold - (Surgical Mesh) [510O(k) K1 02788 and K093799] Sofradim Production PREVADH Th ' Surgical Mesh (Covidien) [510(k) K073287] Artimplant AB… | 2010 |
| * | K073287 | Prevadh MeshSummary page 1…- (Surgical Mesh) [510O(k) K1 02788 and K093799] Sofradim Production PREVADH Th ' Surgical Mesh (Covidien) [510(k) K073287] Artimplant AB Artelon® SportMesh Tm Tissue Reinforcement Mesh [510O(k) K071 887]… | 2008 |
| * | K071887 | Sportmesh or Artelon Tissue ReinforcementSummary page 1…gical Mesh (Covidien) [510(k) K073287] Artimplant AB Artelon® SportMesh Tm Tissue Reinforcement Mesh [510O(k) K071 887] 222 Description Tornie… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 66 ancestors have a recall of any class.
- 6 other devices also cite its predicate K070894.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Tornier® Collagen Coated BioFiber Scaffold is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Tornier® Collagen Coated BioFiber Scaffold is also intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors…
Read the full statement (145 words)
Tornier® Collagen Coated BioFiber Scaffold is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Tornier® Collagen Coated BioFiber Scaffold is also intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.
Tornier® Collagen Coated BioFiber Scaffold is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111337: Tornier Collagen Coated Biofiber Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111337
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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