510(k) · Cleared
ClearedSTR Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soft Tissue Regeneration, Inc. · OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on Nov 21, 2012 as substantially equivalent to K083307 (Synthasome, Inc., 2009) and 2 other predicates after a 212-day review. Its family tree reaches back 10 generations to 1992. 5 later devices descend from it.
- Decided
- Nov 21, 2012
- Review
- 212 days
- Class
- Class II
- Product code
- OWW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K921895 (1992). 37 ancestors in all, the oldest K810428 (1981). 5 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations between
- 3 generations backK052830 SportmeshArtimplant AB · 2006
- 2 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 1 generation backK083307 Synthasome X-RepairSynthasome, Inc. · 2009
- This deviceK121216 STR GraftSoft Tissue Regeneration, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK203267 The BioBrace ImplantBiorez, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK241906 BioBrace® Reinforced ImplantConmed Corporation · 2024
- Descendant · 2 generations on · 1 of its ownK242187 BioBrace®Conmed Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK250395 BioBrace ® RC Delivery SystemConmed Corporation · 2025
Show all 10 generations
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 7 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 6 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 5 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 4 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 3 generations backK052830 SportmeshArtimplant AB · 2006
- 2 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 1 generation backK083307 Synthasome X-RepairSynthasome, Inc. · 2009
- This deviceK121216 STR GraftSoft Tissue Regeneration, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K203267The BioBrace ImplantBiorez, Inc. · 2021 · cites it directly4descendants
- K241906BioBrace® Reinforced ImplantConmed Corporation · 2024 · 2 generations on3descendants
- K242187BioBrace®Conmed Corporation · 2024 · 2 generations on1descendant
- K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025 · 3 generations on0descendants
- K250395BioBrace ® RC Delivery SystemConmed Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −9 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −7 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −6 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −4 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −3 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −2 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| −1 | K083307 | Synthasome X-Repair | Synthasome, Inc. | 2009 | — |
| 0 (this device) | K121216 | STR Graft | Soft Tissue Regeneration, Inc. | 2012 | — |
| +1 | K203267 | The BioBrace Implant | Biorez, Inc. | 2021 | — |
| +2 | K241906 | BioBrace® Reinforced Implant | Conmed Corporation | 2024 | — |
| +2 | K242187 | BioBrace® | Conmed Corporation | 2024 | — |
| +3 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025 | — |
| +3 | K250395 | BioBrace ® RC Delivery System | 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 |
|---|---|---|
| 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 OWW? 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 OWW device
- #1 K241906 BioBrace® Reinforced Implantscore 17.1 · 12 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 |
|---|---|---|---|
| * | K083307 | Synthasome X-RepairSummary page 1…OWT and OWW - Both are Class 11 Classification Panel: General and Plastic Surgery Regulation Number: 21 CFR § 878.3300 C. PREDICATE DEVICES K083307 X-Repair; manufactured by Synthasome, Inc. K071 887 Sport Mesh, Artelon Tissue R… | 2009 |
| * | K071887 | Sportmesh or Artelon Tissue ReinforcementSummary page 1…and Plastic Surgery Regulation Number: 21 CFR § 878.3300 C. PREDICATE DEVICES K083307 X-Repair; manufactured by Synthasome, Inc. K071 887 Sport Mesh, Artelon Tissue Reinforcement; manufactured by Artimplant AB… | 2007 |
| * | K052830 | SportmeshSummary page 1…anufactured by Synthasome, Inc. K071 887 Sport Mesh, Artelon Tissue Reinforcement; manufactured by Artimplant AB K052830 Sport Mesh; manufactured by Artimplant AB November 20, 2012… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203267 | The BioBrace Implant | 2021 | 4 |
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 7 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 37 ancestors has a recall of any class.
- Of its descendants, K203267 (Biorez, Inc., 2021) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K083307.
How does its category compare?
All OWW devicesOWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OWW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWW
81in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWW
No recall names OWW since 2007.
Adverse event reports per year · OWW
2in 2025
MAUDE reports naming product code OWW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | 81 | 0 | 0 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The STIR GRAFT is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
The STIR GRAFT 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.
The STIR GRAFT is not intended to replace normal body structures 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 bone, provide mechanical strength for the tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121216: STR Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121216
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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