HyperSuture All Green Extension Line

K254275 · Threadstone, LLC · GAT · Mar 23, 2026 · General, Plastic Surgery

Device Facts

• Record ID: K254275
• Device Name: HyperSuture All Green Extension Line
• Applicant: Threadstone, LLC
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Mar 23, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HyperSuture™ All Green Extension sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

Device Story

HyperSuture All Green Extension is a non-absorbable surgical suture system consisting of braided multifilament ultra-high molecular weight polyethylene (UHMWPE) strands. Available in various configurations including cables, loops, and tapes, with or without pre-attached 302 AISI stainless steel needles. Used by surgeons in clinical settings for soft tissue approximation, ligation, cardiovascular procedures, and orthopedic allograft fixation. The device provides mechanical support to tissues during healing. It is a passive implantable device; no electronic or software components are involved. Safety and effectiveness are established through physical performance testing per USP standards and biocompatibility assessments.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing per USP 43 performance requirements (diameter, tensile strength, needle attachment) and biocompatibility evaluation per ISO 10993-1:2018.

Technological Characteristics

Material: UHMWPE (suture), 302 AISI stainless steel (needle). Additive: D&C Green No. 6 (<0.75% by weight). Configurations: Cables, loops, tapes (24"-40" lengths). Sizes: USP #2-0 to #5; 1.0mm-2.0mm tapes. Performance: Tested per USP 43. Biocompatibility: ISO 10993-1:2018. Electrical conductivity: <2 S/m.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including cardiovascular surgery and orthopedic allograft tissue procedures.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• HyperSuture (K230311)
• HyperSuture White/Green Extension (K242201)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

March 23, 2026

Threadstone, LLC
Steven Boudouris
Director of Operations
1035 Benfield Blvd.
Suite H
Millersville, Maryland 21108

Re: K254275
Trade/Device Name: HyperSuture All Green Extension Line
Regulation Number: 21 CFR 878.5000
Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture
Regulatory Class: Class II
Product Code: GAT
Dated: December 29, 2025
Received: December 30, 2025

Dear Steven Boudouris:

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.

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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

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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TEK N. LAMICHHANE -S

Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Infection Control
and Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K254275 | |
| Device Name HyperSutureTM All Green Extension Line | |
| Indications for Use (Describe) HyperSutureTM All Green Extension sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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510(k) Summary

K254275

# 510(k) Summary of Threadstone HyperSuture™ All Green Extension

## Submitter Information

Applicant: Threadstone L.L.C.
Address: 1035 Benfield Blvd, Suite H, Millersville, MD 21163, USA
Phone Number: 443-790-6536
Fax Number: N/A
Registration Number: 3017499940
Contact Person: Steven Boudouris
[e-mail]
Date of Preparation: 13FEB2026

## Device Name

Trade Name: HyperSuture™ All Green Extension Line
Common or Usual Names: Polyblend Suture, Non-absorbable Surgical Sutures
Classification Name: Nonabsorbable poly(ethylene terephthalate) Surgical Suture

## Device Classification

FDA Class: II
Product Classification: 21 CFR 878.5000
Suture, nonabsorbable, synthetic, polyethylene
Classification Code: GAT
Review Panel: General &amp; Plastic Surgery
Premarket Review: Office of Device Evaluation
Division of Surgical Devices, Plastic and Reconstructive
General Surgery Devices Branch

## Predicate Device

K230311 – HyperSuture™ (GAT – 21 CFR 878.5000
Suture, nonabsorbable, synthetic, polyethylene)

K242201 – HyperSuture™ White/Green Extension (GAT – 21 CFR 878.5000
Suture, nonabsorbable, synthetic, polyethylene)

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# 510(k) Summary

K254275

## Device Description Summary:

The Threadstone HyperSuture All Green Extension cables, loops, and tapes are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture All Green Extension cables and tapes are available in 36 inches and 40 inches in length. The loop configurations are available in 24" or 2" loop configurations. HyperSuture All Green Extension cable, loops, and tape sizes include USP #2-0, USP #0, USP #1, USP #2, USP #3, USP #5, and 1.0mm tape, 1.2mm tape, 1.5mm tape, 1.8mm tape, 2.0mm tape. All variations of the suture, cables, loops, and tapes, are available with or without pre-attached needles.

## Intended Use / Indication for Use:

HyperSuture™ All Green Extension sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

## Substantial Equivalence Summary and Comparison of Technical Characteristics

The Threadstone HyperSuture™ All Green Extension devices are substantially equivalent to the predicate and reference devices. The devices have the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate devices. Both the candidate and the predicate devices are manufactured, packaged, and sterilized at the same location, using the same process. Both are composed of the same UHMWPE material for suture and 302 AISI stainless steel for needle and are tested per USP 43 performance requirements for diameter, tensile strength and needle attachment.

The minor differences in technical characteristics are limited to the color additive content as well as addition of Looped products and USP #0, USP #1, USP #3, 1mm, 1.2mm, and 1.8mm sizes. The candidate consists of green dyed UHMWPE as opposed to white UHMWPE and 6-0 black nylon-6,6 tracers in the predicate device. Less than 0.75% by weight D&amp;C Green No.6 was used per 21 CFR 74.3206 and tests on the final device were conducted to show that the electrical conductivity is less than 2 S/m.

Biocompatibility testing including implantation studies, chemical characterization, toxicology assessments confirms that there is no residual risk associated with the changes made.

Other technological characteristics such as materials, dimensions, sterilization, manufacturing processes, mechanical strengths (i.e., tensile strength, and needle attachment strength), shelf-life, packaging, and labels are unchanged.

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# 510(k) Summary

K254275

## Non-Clinical Testing Summary:

The Threadstone HyperSuture™ All Green Extension sutures (both cables, loops, and tapes) meet requirements established by the United States Pharmacopeia (USP). The sutures were tested per USP performance requirements for diameter, length, needle attachment and tensile strength. Materials were evaluated per ISO 10993-1:2018 – Biological Evaluation of Medical Devices. The candidate devices demonstrated substantial equivalence to the predicate devices.

## Conclusion:

Based on the results of completed performance testing inclusive of physical testing, biocompatibility testing, it can be concluded that the Threadstone HyperSuture™ All Green Extension is substantially equivalent in terms of safety and effectiveness to their predicate devices.