STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices

K252047 · ETHICON, Inc. · NEW · May 18, 2026 · General, Plastic Surgery

Device Facts

• Record ID: K252047
• Device Name: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
• Applicant: ETHICON, Inc.
• Product Code: NEW · General, Plastic Surgery
• Decision Date: May 18, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K252047 · May 18, 2026	STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices	ETHICON, Inc.	Premier Healthcare Database (PHD); Retrospective observational clinical study data	The sponsor utilized two retrospective observational studies to provide clinical evidence for the use of the device in high-tension soft tissue closure, specifically evaluating postoperative complications such as internal wound dehiscence and incisional hernia.	Retrospective study; Real-world data; High-tension closure; Incisional hernia; Wound dehiscence

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective, single-arm, multi-institution cohort study in the Premier Healthcare Database (PHD); Retrospective, single-arm, multi-institution cohort study; Follow-up/Duration: 30 days post-index procedure	Patients undergoing wound closure in high-tension areas; Number of Sites: Multi-institution	Not applicable for this study	Incidence of postoperative complications of internal wound dehiscence
Retrospective, comparative cohort study; Retrospective, comparative cohort study; Follow-up/Duration: 12 months post-index procedure	Patients undergoing open abdominal surgery using STRATAFIX Symmetric for high tension closure	Not specified	Cumulative incidence of incisional hernia; secondary endpoints of internal wound dehiscence

Indications for Use

The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

Device Story

STRATAFIX™ Symmetric PDS™ Plus is an antibacterial, synthetic, absorbable monofilament suture made of poly(p-dioxanone) containing triclosan. Device features unidirectional anchors and a fixation tab, eliminating the need for surgical knots. Used by surgeons for soft tissue approximation, including high-tension areas like abdominal wall, knee, hip, and lumbar fascia. The device provides mechanical tissue holding via barbs. Clinical benefit includes secure wound closure without knot-related complications. The update to the device labeling specifically clarifies its use in high-tension surgical applications.

Clinical Evidence

Evidence includes a literature review of 44 publications (25 abdominal, 19 orthopedic) and two retrospective observational studies. Literature review showed 96% of clinical comparison papers (n=25) demonstrated performance similar to non-barbed sutures. Retrospective studies evaluated postoperative complications, specifically internal wound dehiscence at 30 days and cumulative incidence of incisional hernia within 12 months post-index procedure in high-tension abdominal surgery.

Technological Characteristics

Synthetic absorbable monofilament suture composed of poly(p-dioxanone) (C4H6O3)x. Contains triclosan (max 2360 μg/m). Features unidirectional anchors and fixation tab. Sterilized via Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for general soft tissue approximation where use of an absorbable suture is appropriate. Includes high tension closure applications such as abdominal wall fascia, knee extensor mechanism fascia, deep hip fascia, deep lumbar fascia, and ventral hernia fascial closure with mesh. Contraindicated for full (>10cm) laparotomy incisions or patients with BMI >30kg/m2.

Regulatory Classification

Identification

An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for the 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

• STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (K182873)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 18, 2026

ETHICON, Inc.
Samantha Mecker
Associate Director, Regulatory Affairs
1000 Rte. 202 S.
Raritan, New Jersey 08869

Re: K252047
Trade/Device Name: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
Regulation Number: 21 CFR 878.4840
Regulation Name: Absorbable polydioxanone surgical suture
Regulatory Class: Class II
Product Code: NEW
Dated: March 31, 2026
Received: March 31, 2026

Dear Samantha Mecker:

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 & 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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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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 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 (8/23)
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: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252047 | |
| Device Name STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | |
| Indications for Use (Describe) The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate. | |
| 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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K252047 - Page 1 of 3

# 510(k) Summary (K252047)

Submitter: Ethicon Inc. a Johnson & Johnson company
1000 US-202
Raritan, New Jersey 08869

Contact Person: Samantha Mecker
Ethicon, Inc. a Johnson & Johnson company
e-mail: [e-mail]
Phone: [phone]

Date Prepared: May 15, 2026

Device Trade Name: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices

Device Common Name: Suture, Surgical, Absorbable, Polydioxanone

Class: II

Classification Name: Suture, Surgical, Absorbable, Polydioxanone
(21 CFR 878.4840)

Product Code: NEW

| Legally Marketed Predicate Devices | 510(k) Number | Product Code |
| --- | --- | --- |
| STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device | K182873 | NEW |

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K252047 - Page 2 of 3

## Device Description:

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is $(\mathrm{C4H6O3})_{\mathrm{x}}$. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than $2360~\mu \mathrm{g / m}$. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is dyed with D&C Violet No. 2.

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. Polydioxanone has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

## Indications for Use:

The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

The indications for use are identical between the subject and predicate devices.

## Comparison of Technological Characteristics with the Predicate Devices:

The Instructions for Use of the subject devices are updated with the following language to add the on-label use of high tension closure. The subject devices differ from their respective predicate devices only in the Instructions for Use (IFU).

Ethicon will add the following language to the Actions section of the IFU:

The barbs are uniquely designed and provide maximum holding in soft tissue where PDS™ Plus Suture is commonly used, including in high tension areas such as abdominal wall fascia, knee extensor mechanism fascia during a total knee replacement, deep hip fascia used during a total hip replacement, deep lumbar fascia during spine surgery, closure of mini-laparotomy incisions in patients with BMI less than $30\mathrm{kg} / \mathrm{m}^2$, and ventral hernia fascial closure with mesh.

As Ethicon adds high tension use specifically on-label in our IFU, Ethicon will also include the following language in the Warnings section of the IFU as additional clarification related to the use in high tension closure in abdominal wall surgery applications:

Safety and effectiveness has not been established in closure of full $(>10\mathrm{cm})$ laparotomy incisions, or in patients with BMI $>30\mathrm{kg} / \mathrm{m}^2$ and use in these scenarios could result in wound dehiscence or incisional hernia. This should not supersede good clinical judgement.

There are no changes to the technological characteristics of the STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices.

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K252047 - Page 3 of 3

Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] has been followed and it was determined that subject Devices are substantially equivalent to the predicate in that they share:

a) the same fundamental scientific technology,
b) the same intended use,
c) the same design,
d) the same materials,
e) equivalent packaging materials and configuration,
f) the same labeling components
g) the same sterilization process (Ethylene Oxide)
h) the same sterility assurance level (SAL) is 10-6.

## Performance Data:

A literature review was performed to support update of the STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices labeling to describe high tension closure, inclusive of 25 publications in abdominal procedures and 19 publications in orthopedic procedures. Study endpoints ranged from 30 days to 2 years post procedure. While each paper had different levels of reliability, 96% of the clinical comparison papers (12 studies evaluating abdominal wall procedures and 13 evaluating orthopedic procedures) show similar performance of STRATAFIX Symmetric versus non-barbed sutures.

Additionally, two retrospective observational clinical studies were performed to provide clinical evidence using real-world data from routine clinical practice:

1. A retrospective, single-arm, multi-institution cohort study in the Premier Healthcare Database (PHD) was conducted to evaluate clinical outcomes of the STRATAFIX Symmetric PDS™ Plus Knotless Tissue Control Device for wound closure in high-tension areas in clinical practice, specifically focusing on the incidence of postoperative complications of internal wound dehiscence at 30 days post-index procedure. To contextualize the study findings, a literature review was performed to evaluate the incidence of outcomes of interest in the current study versus prior literature.
2. A second retrospective, comparative cohort study was conducted to provide evidence on clinical outcomes of interest among patients undergoing open abdominal surgery using STRATAFIX Symmetric for high tension closure. Specifically, this study primarily evaluated the non-inferiority in the cumulative incidence of incisional hernia within 12 months post-index procedure with secondary endpoints of internal wound dehiscence.

## Substantial Equivalence Conclusion:

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are substantially equivalent to the predicate device.