510(k) · Cleared
ClearedSynthasome X-Repair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthasome, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Mar 27, 2009 as substantially equivalent to K071887 (Artimplant AB, 2007) and 2 other predicates after a 137-day review. Its family tree reaches back 9 generations to 1992. 9 later devices descend from it.
- Decided
- Mar 27, 2009
- Review
- 137 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K921895 (1992). 36 ancestors in all, the oldest K810428 (1981). 9 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations between
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK052830 SportmeshArtimplant AB · 2006
- 1 generation backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- This deviceK083307 Synthasome X-RepairSynthasome, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK121216 STR GraftSoft Tissue Regeneration, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK203267 The BioBrace ImplantBiorez, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK241906 BioBrace® Reinforced ImplantConmed Corporation · 2024
- Descendant · 3 generations on · 1 of its ownK242187 BioBrace®Conmed Corporation · 2024
- Descendant · 4 generations on · 0 of its ownK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025
Show all 9 generations
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 6 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 5 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 4 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK052830 SportmeshArtimplant AB · 2006
- 1 generation backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- This deviceK083307 Synthasome X-RepairSynthasome, Inc. · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K121216STR GraftSoft Tissue Regeneration, Inc. · 2012 · cites it directly5descendants
- K203267The BioBrace ImplantBiorez, Inc. · 2021 · 2 generations on4descendants
- K241906BioBrace® Reinforced ImplantConmed Corporation · 2024 · 3 generations on3descendants
- K242187BioBrace®Conmed Corporation · 2024 · 3 generations on1descendant
- K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −8 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −6 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −5 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −3 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −2 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −1 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| 0 (this device) | K083307 | Synthasome X-Repair | Synthasome, Inc. | 2009 | — |
| +1 | K121216 | STR Graft | Soft Tissue Regeneration, Inc. | 2012 | — |
| +2 | K203267 | The BioBrace Implant | Biorez, Inc. | 2021 | — |
| +3 | K241906 | BioBrace® Reinforced Implant | Conmed Corporation | 2024 | — |
| +3 | K242187 | BioBrace® | Conmed Corporation | 2024 | — |
| +4 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 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 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K071887 | Sportmesh or Artelon Tissue ReinforcementSummary page 1…edicate Device Identification: * SportMeshTM/Artelon® Tissue Reinforcement (K071887) * Artimplant AB SportMeshTM (K052830)… | 2007 |
| * | K052830 | SportmeshSummary page 1…MeshTM/Artelon® Tissue Reinforcement (K071887) * Artimplant AB SportMeshTM (K052830) * Vicryl Mesh (K810428) Device Description: The X-Repair is a bioabsorbable, rec… | 2006 |
| * | K810428 | VicrylSummary page 1…Reinforcement (K071887) * Artimplant AB SportMeshTM (K052830) * Vicryl Mesh (K810428) Device Description: The X-Repair is a bioabsorbable, rectangular, double-layered, flexible, woven surgical mesh manufactured fr… | 1981 |
What descends from it? (9)
4 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 17 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 36 ancestors has a recall of any class.
- Of its descendants, K121216 (Soft Tissue Regeneration, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K071887.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
X-Repair is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
X-Repair is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
X-Repair is not intended to replace normal body structure or 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/K083307 · printed Nov 3, 2026
Cite this page
510(k) Report. “K083307: Synthasome X-Repair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K083307
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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