510(k) · Cleared
ClearedTeKBrace Solo Soft Tissue Reinforcement Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theramicro · QUW Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Cleared on Aug 18, 2026 as substantially equivalent to K261621 (Theramicro, 2026) and 1 other predicate after an 18-day review. Its family tree reaches back 17 generations to 1993. 1 of the 162 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 18, 2026
- Review
- 18 days
- Class
- Class II
- Product code
- QUW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K931386 (1993). 161 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet. 1 of the 162 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 13 generations between
- 3 generations backK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- 2 generations backK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
- 1 generation backK261621 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
- This deviceK262729 TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
Show all 17 generations
- Root · 17 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 16 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 15 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 14 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 13 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 12 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 11 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 10 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 9 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 8 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 7 generations backK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- 6 generations backK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- 5 generations backK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- 4 generations backK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- 3 generations backK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- 2 generations backK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
- 1 generation backK261621 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
- This deviceK262729 TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
Class I recalls in this family
- K963967 Glycar Pericardial Patch6 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −16 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −15 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −14 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −13 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −12 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −11 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −10 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −9 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −8 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| −7 | K051485 | Ams Pelvic Floor Repair System | American Medical Systems, Inc. | 2005 | — |
| −6 | K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen… | American Medical Systems, Inc. | 2008 | — |
| −5 | K090288 | Orthadapt PR | Pegasus Biologics, Inc. | 2009 | — |
| −4 | K112786 | Proseries Bioimplants-Proankle/Procuff | Synovis Orthopedic and Woundcare, Inc. | 2011 | — |
| −3 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| −2 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
| −1 | K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
| 0 (this device) | K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1996 | 11 | 0 |
| 1997 | 7 | 1 |
| 1998 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 11 | 0 |
| 2001 | 8 | 0 |
| 2002 | 11 | 0 |
| 2003 | 11 | 0 |
| 2004 | 12 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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.
1 device in this family has a Class I recall. 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 QUW device
- #1 K251063 TekBrace Solo Soft Tissue Reinforcement Devicescore 19.6 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K261621 | TekBrace Solo Soft Tissue Reinforcement DeviceSummary page 5…Product Code: QUW, FTL, OWX Primary Predicate: TheraMicro TeKBrace Solo Soft Tissue Reinforcement Device – K261621 Device Description: The TheraMicro TeKBrace Solo Soft Tissue Reinforcement Device is a single use device intended to be used f… | 2026 |
| * | K251063 | TekBrace Solo Soft Tissue Reinforcement DeviceSummary page 5…tapers down to cords at both ends. The product is substantially equivalent in material and manufacturing compared to the TeKBrace Solo Soft Tissue Reinforcement Device (K251063 & K261621).The TeKBrace solo configurations included in this submission are similar to the existing TheraMicro TeKBrace Solo devi… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K963967Glycar Pericardial PatchGlycar, Inc. · 1997 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 161 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All QUW devicesQUW Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QUW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QUW
Too few QUW 510(k)s in any year since 2007 to give a median.
Recalls per year · QUW
No recall names QUW since 2007.
Adverse event reports per year · QUW
No MAUDE report names QUW since 2007.
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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The TeKBrace Solo Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular…
Read the full statement (138 words)
The TeKBrace Solo Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.
The TeKBrace Solo Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices used to attach the tissue to the bone, provide mechanical strenQth for the repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262729: TeKBrace Solo Soft Tissue Reinforcement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262729
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026