PDO Thread Brands Guide (2026): 4 FDA-Cleared PDO Threads Compared

For med spa owners, medical directors and injectors. Updated October 22, 2026 · Prepared by Prospyr. PDO threads are absorbable polydioxanone sutures, and in the US they reach practices through the FDA's 510(k) clearance pathway, each with a specific cleared indication. Prospyr makes practice software for med spas, plastic surgery and wellness practices, not threads, and none of the companies below is a Prospyr product or partner. This is a reference guide, not a ranking. Inclusion comes from the FDA's 510(k) database and the FDA's device identification database (GUDID), and each company summary reflects what the company publishes on its own website, checked October 2026. This article is not medical advice, does not describe technique, and makes no claim about the safety, results or duration of any product. Confirm the cleared indication, labeling and account terms in writing before you buy.

What are PDO threads, and which ones are FDA-cleared?

PDO threads are sterile, absorbable sutures made of polydioxanone (PDO), usually supplied preloaded in a needle or cannula, and in the US they are regulated as Class II absorbable polydioxanone surgical sutures (FDA product code NEW) that reach the market through 510(k) clearance, not FDA approval. The detail that matters most is the cleared indication. Most PDO thread clearances we found cover "soft tissue approximation where use of an absorbable suture is appropriate," and several say in the same sentence that the suture "is not intended for lifting and supporting tissues." One brand on this list, MINT, also holds clearances for mid-face suspension surgery. Four companies sell PDO threads to US practices with a clearance we could match in the FDA's databases as of October 2026: Hans Biomed USA (MINT), PDO Max, V Soft Lift and ApolloMed Innovations (AMI PDO Threads).

The 4 FDA-cleared PDO thread brands at a glance

How we chose this list

This guide has one inclusion rule: the thread must trace to an FDA 510(k) clearance we could find ourselves. We searched the FDA's 510(k) database for product code NEW (absorbable polydioxanone surgical sutures), read each clearance's indications for use, and used the FDA's GUDID to match brand names on the box to a clearance number. We then loaded each company's own website to confirm it sells PDO threads to US practices today.

• Clearance first. A product described as "FDA approved" or "FDA cleared" without a clearance we could find is not included, however widely it is sold.
• Indications as written. We quote the indication from the FDA record, not the company's description of it.
• No technique, no results. We do not describe placement, thread counts, patient selection or outcomes.
• Company terms only where published.

Brands are listed alphabetically by company. The order is not a ranking or a measure of results. We expected more brands; several widely marketed threads did not trace to a clearance we could confirm, or we could not confirm a current US seller (see "Other names in the FDA database" below).

1AMI PDO Threads (ApolloMed Innovations)#

ApolloMed Innovations, based in the Atlanta, Georgia area, sells AMI PDO Threads, which its site calls "ApolloMed's in-house brand of FDA-cleared PDO threads," in smooth mono, volumizing, unidirectional barbed and bidirectional barbed styles. The FDA's GUDID lists "AMI Custom Crafted" and "AMI Standard Barb" products labeled by Feeltech Co., Ltd. of Korea under clearance K172602 (GUDID listing). That clearance, granted November 14, 2018, covers a barbed polydioxanone suture "indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues." (FDA 510(k) K172602)

What stands out:

• Published prices. Its online shop listed prices for each thread style when we checked, with smooth mono threads at a $200 regular price and barbed threads at $500 (as of October 2026; confirm what quantity each price covers).
• Training. ApolloMed advertises a two-day, hands-on master PDO training course for physicians and practitioners, with a model registration page.
• Wider catalog. It also sells microneedling, PRP and other aesthetic products.

Right for: practices that want to see thread prices before a sales call. Ask: which clearance number and labeler appear on each box you will receive, and how the product descriptions on its site relate to the cleared indication.

Visit AMI PDO Threads (ApolloMed Innovations) →

2MINT (Hans Biomed USA)#

Hans Biomed USA markets MINT PDO threads, made by Hans Biomed Corporation of Korea. Its product page lists "FDA Clearance (K130191, K192423, K220549)," and the FDA database shows a fourth clearance, K254238 for MINT MONO Sutures, granted September 18, 2026. As listed by the FDA:

• K130191 (June 12, 2013): soft tissue approximation where the use of absorbable sutures is appropriate (FDA 510(k) K130191).
• K192423 (September 9, 2020): "indicated for use in mid-face suspension surgery to temporarily fixate the cheek subcutaneous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds" (FDA 510(k) K192423).
• K220549 (March 7, 2023): the MINT Product Family (MINT, MINT Lift and MINT-I) "indicated for use in soft tissue approximation where use of a barbed absorbable suture is appropriate," and "also indicated for use in face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position" (FDA 510(k) K220549).
• K254238 (September 18, 2026): MINT MONO Sutures for soft tissue approximation; the FDA record adds, "The suture is not intended for lifting or filling aesthetic uses" (FDA 510(k) K254238).

What stands out:

• Suspension indication. Of the brands on this list, MINT is the only one with a clearance for mid-face suspension surgery. Hans Biomed's site describes MINT as "the first and only device of its kind to have three FDA clearances for skin approximation, nasolabial fold depth reduction, and facial suspension surgery."
• Several product types. The product page lists MINT FINE+, PETIT+, 17+, FIX, FIX-MINI, TIP, UP, EASY and 43, plus MINT Microcannula.
• Training. Hands-on training is open to practitioners with an active US medical license, in small groups at a trainer's clinic, in Foundational, Intermediate and Advanced levels, with listed sessions in many states. Online training runs through Hans Academy. Pricing is by inquiry.

Right for: practices, including plastic surgery practices, that want a thread whose clearances include a suspension indication. Ask: which MINT products fall under which clearance, since the indications differ, and what training costs at each level.

Visit MINT (Hans Biomed USA) →

3PDO Max#

PDO Max, based in Liverpool, New York, sells threads-in-cannula in smooth, barbed, twisted, nose and multi-thread styles. Its site states, "PDO Max threads are FDA cleared for soft tissue approximation where an absorbable suture is appropriate," and lists K190245 and K210871. The FDA records:

• K190245 (June 4, 2019), PDO MAXX Threads barbed suture: "indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues." (FDA 510(k) K190245)
• K210871 (December 17, 2021), PDO Max Suture with Dual Needle: the same indication, including that it is not intended for lifting and supporting tissues (FDA 510(k) K210871).

What stands out:

• US company with its own clearances. PDO Max is the applicant on both clearances, and the site states the company is ISO 13485 certified and its manufacturer MDSAP certified.
• Training formats. Private in-office, small-group and online training, with a certificate of completion.
• Related products. The site also sells microcannulas, a PDO and hyaluronic acid serum (PDO AfterGlo), the Glowpin multi-needle stimulator and LúmEnvy skin boosters. A practitioner portal handles account access.

Right for: practices that want a US-based thread company that holds its own clearances. Ask: pricing (not published), what in-office training includes, and which products ship under which clearance.

Visit PDO Max →

4V-Soft Line (V Soft Lift)#

V Soft Lift, a Swedish company based in Stockholm, sells V-Soft Line PDO threads to US practices through its US site, in mono (smooth) and Barb Star (barbed) styles plus accessories. Its global site states, "Product selection, placement and use must comply with the cleared indication and applicable Instructions for Use." The site does not list a clearance number. The FDA's GUDID lists V-Soft Line products labeled by Feeltech Co., Ltd. under clearances K172602, K250107 and K251414 (GUDID listing). The two newest clearances carry the same indication as K172602: soft tissue approximation, "on the skin for dermatological applications only," and "not intended for lifting and supporting tissues" (FDA 510(k) K250107, October 15, 2025; FDA 510(k) K251414, October 20, 2025).

What stands out:

• Training options. On-demand, live and private courses, and the company states it partners with the AAFE on training.
• Practitioner accounts. An injector login and account sign-up handle ordering; thread prices are not published.
• Marketing materials. The US site offers practice marketing materials alongside the threads.

Right for: practices that want a thread company with on-demand training. Ask: the clearance number on each product you order, thread pricing, and how the suggested patient fees on its US site were set.

Visit V-Soft Line (V Soft Lift) →

Other names in the FDA database

These products appear in the FDA's 510(k) database or GUDID, but we could not confirm a current US seller on a company website in October 2026, so they are not listed above.

• Miracu (DongBang Medical, made by Feeltech): cleared under K172602 and, for MONO threads, K251414, both for soft tissue approximation and not for lifting and supporting tissues. DongBang showed Miracu at The Aesthetic Show 2026 in Las Vegas.
• Barbed PDO Suture (Sutura Medical Technology, Miami): cleared June 12, 2026 (K252171) "for placement in the subcutaneous plane for temporary fixation of the cheek adipose layer in midface suspension surgery." We found no product website.
• Secret Line and i-Thread (Hyundae Meditech, Korea): cleared under K240389 and K242571 for soft tissue approximation, "for dermatological use only," and not for lifting and supporting tissues.
• Renovatio (Bonago Medical Solutions, labeled under Dongwon Medical's K160761): cleared for soft tissue approximation. The brand's site did not show product details we could read.

Silhouette InstaLift is a cleared thread for mid-face suspension surgery (K200140), but it is made of poly(glycolide/L-lactide), not PDO, so it is outside this guide. NovaThreads and SILK PDO are marketed as FDA cleared or approved; we could not match either brand name to a clearance in the FDA's databases.

Questions to ask any PDO thread company

1. What is the 510(k) number on the box? Look it up yourself in the FDA's 510(k) database and read the indications for use. The GUDID, searchable by the barcode on the box, shows which clearance a specific product ships under.
2. Does the cleared indication match how you plan to market the treatment? Many PDO thread clearances state the suture is not intended for lifting and supporting tissues. Keep your website, ads and consent forms inside the cleared indication, and have your medical director and counsel review them. See our list of medical advertising compliance reviewers.
3. Who may place threads in your state? Scope of practice and supervision rules vary by state. Confirm with your state board and your medical director, and make sure your malpractice coverage names the procedure.
4. What training comes with the account, and what does it cost? Ask whether it is hands-on with live patients, who teaches it, and whether new providers can be trained later.
5. How are complications supported? Ask what the company provides and keep your own plan. See our list of complication management courses.
6. How do lots and recalls reach you? Get the process in writing, and know the FDA MedWatch route for reporting adverse events.

Where Prospyr fits

Threads come in many styles and lengths, and each one has a lot number. Prospyr's inventory management keeps thread and cannula counts and lots in one place, the aesthetic EMR records the product, lot and consent on the patient's chart, and packages let you sell a treatment plan as a series. For photos that document each visit, see our list of before-and-after photo setups, and for cannulas, see cannulas and needles for fillers. To see how it would work for your practice, book a practice demo.

Frequently asked questions

Are PDO threads FDA approved?

No. PDO threads are medical devices that reach the US market through 510(k) clearance, which means the FDA found them substantially equivalent to a legally marketed device. That is different from approval. Some marketing uses the word "approved"; check the clearance number and its indication in the FDA's 510(k) database.

Are PDO threads FDA-cleared for lifting?

Most PDO thread clearances we found cover soft tissue approximation only, and several state that the suture "is not intended for lifting and supporting tissues." MINT's K192423 and K220549 clearances, and Sutura Medical's K252171, include mid-face suspension surgery. Read the indication for the exact product you buy.

What is the difference between PDO, PLLA and PCL threads?

They are different absorbable materials, and the FDA regulates them under different suture categories. PDO is polydioxanone. Silhouette InstaLift, for example, is made of poly(glycolide/L-lactide) and is cleared under a different regulation. Each product has its own clearance and labeling.

How do I check whether a thread is FDA-cleared?

Search the FDA's 510(k) database by company or device name, or search the FDA's GUDID by the device identifier printed under the barcode on the box. GUDID shows the brand, labeler and clearance number for that exact product.

Want your company considered?

We review this guide quarterly. Companies that sell FDA-cleared PDO threads to US practices can send their website, clearance numbers and what they offer practices to info@prospyrmed.com. Inclusion is editorial and not paid.

Editorial scope

This guide is based on the FDA's 510(k) database, the FDA's Global Unique Device Identification Database (GUDID) and each company's public website, checked October 2026 with AI-assisted research. Companies did not review this article before publication. It is not medical advice, a comparison of product safety or results, or a substitute for each product's FDA-cleared labeling and your state's scope-of-practice rules. Read our methodology or report a correction.