(56 days)
No.
The device description and intended use indicate it is a physical implant for soft tissue reinforcement and does not mention any functionality related to AI, DNN, or ML.
Yes
The device is intended for the reinforcement of soft tissues during tendon and ligament repair surgery, which falls under the definition of a therapeutic intervention to treat a medical condition.
No
The device is described as a "Soft Tissue Reinforcement Device" intended for reinforcement during tendon and ligament repair surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical implant manufactured from non-absorbable polyethylene terephthalate (PET) fibers, which is a hardware component. Its intended use is for reinforcement of soft tissues during surgery, indicating a physical interaction within the body.
No.
The device is an implant for soft tissue reinforcement during surgery, not a diagnostic tool for in-vitro analysis of samples.
N/A
Intended Use / Indications for Use
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 strength for the repair.
Product codes
QUW, FTL, OWX
Device Description
The TheraMicro TekBrace Solo Soft Tissue Reinforcement Device is a single use device intended to be used for reinforcement of soft tissue. The product is offered in a central tubular weave tape that tapers down to cords at both ends. The implant is available in two sizes. The device will have pockets which provide access to the inside of the tubular section. The product is substantially equivalent in material and manufacturing compared to the Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978 and K220091). TekBrace Solo is similar to the Xiros Infinity-Lock predicate in intended use, material and design, including a central tubular section tapering down to cords at the end.
TekBrace Solo is manufactured from non-absorbable polyethylene terephthalate (PET), commercially known as polyester. The implant is manufactured from fibers of long-chain, linear polyester having recurrent aromatic rings. The device also incorporates Cottony II green PET suture for pocket location visibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, tendon, ligament, 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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tensile testing has been performed on the subject TekBrace Solo devices to determine ultimate tensile strength and fixation strength and the results have shown them to be substantially equivalent to the predicate devices. Additionally, engineering analysis of tensile strength following fatigue testing was performed and found the device to be substantially equivalent to the predicate. Endotoxin testing was performed on the subject device and all results were within acceptable limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device – K222978
Reference Device(s)
Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device – K220091
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 30, 2025
TheraMicro
Christine Scifert
Head of RA/QA
51 Germantown Court
Suite 200
Cordova, Tennessee 38018
Re: K251063
Trade/Device Name: TekBrace Solo Soft Tissue Reinforcement Device
Regulation Number: 21 CFR 878.3300
Regulation Name: Surgical Mesh
Regulatory Class: Class II
Product Code: QUW, FTL, OWX
Dated: April 4, 2025
Received: April 4, 2025
Dear Christine Scifert:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K251063 - Christine Scifert
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K251063 - Christine Scifert
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
K251063
Page 1 of 1
Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251063 |
|---|---|
| Please provide the device trade name(s). |
TekBrace Solo Soft Tissue Reinforcement Device
| Please provide your Indications for Use below. |
|---|
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 strength for the repair.
Please select the types of uses (select one or both, as applicable).
- ☒ Prescription Use (Part 21 CFR 801 Subpart D)
- ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
TekBrace Solo Soft Tissue Reinforcement Device
Page 1 of 1
Page 5
510(k) Summary
TeKBrace Solo Soft Tissue Reinforcement Device
4 April 2025
Company: TheraMicro
51 Germantown Court, Suite 200
Cordova, TN 38018
Company Contact: Christine Scifert
Head of RA/QA
TheraMicro
Phone: (901) 831-8053
Email: cscifert@theramicro.com
Trade Name: TeKBrace Solo Soft Tissue Reinforcement Device
Common Name: mesh, surgical, non-resorbable, orthopedics, reinforcement of ligament
Classification: Class II
Regulation: 21 CFR 878.3300 (Surgical mesh)
Panel: General and Plastic Surgery
Product Code: QUW, FTL, OWX
Primary Predicate: Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device – K222978
Device Description:
The TheraMicro TekBrace Solo Soft Tissue Reinforcement Device is a single use device intended to be used for reinforcement of soft tissue. The product is offered in a central tubular weave tape that tapers down to cords at both ends. The implant is available in two sizes. The device will have pockets which provide access to the inside of the tubular section. The product is substantially equivalent in material and manufacturing compared to the Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978 and K220091). TekBrace Solo is similar to the Xiros Infinity-Lock predicate in intended use, material and design, including a central tubular section tapering down to cords at the end.
TekBrace Solo is manufactured from non-absorbable polyethylene terephthalate (PET), commercially known as polyester. The implant is manufactured from fibers of long-chain, linear polyester having recurrent aromatic rings. The device also incorporates Cottony II green PET suture for pocket location visibility.
K251063
Page 1/2
Page 6
Indications for Use:
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 strength for the repair.
Substantial Equivalence:
The subject TekBrace Solo Soft Tissue Reinforcement Device is substantially equivalent to the following predicate devices:
Primary Predicate:
Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device – K222978
Additional Predicates:
Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device – K220091
There are insignificant differences between the subject TeKBrace Solo device and the predicates. The Indications for Use for the primary predicate device is identical to that of the subject device. The TekBrace Solo Soft Tissue Reinforcement devices included in this submission are substantially equivalent to the predicate devices in design, material and manufacturing. TekBrace Solo has the same intended use and the same principles of operation as the predicates devices. The subject device also performs equivalent to or better than the predicate devices. Therefore, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
Tensile testing has been performed on the subject TekBrace Solo devices to determine ultimate tensile strength and fixation strength and the results have shown them to be substantially equivalent to the predicate devices. Additionally, engineering analysis of tensile strength following fatigue testing was performed and found the device to be substantially equivalent to the predicate. Endotoxin testing was performed on the subject device and all results were within acceptable limits.
Conclusion:
The subject device is determined to be substantially equivalent to the predicate devices.
K251063
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