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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears ArthroTAK's Sutureless Tendon Anchor Kit for Biceps Tenodesis

The 510(k) covers a single-use PEEK implant that is driven through the tendon into bone with a mallet, with no sutures or knot-tying, the company said.

By News DeskMay 5, 20262 min read
ArthroTAK Tendon Anchor Kit implant and inserter
The ArthroTAK Tendon Anchor Kit, as pictured in the company's press release. Photo: ArthroTAK · Company press image supplied with the press release (courtesy of ArthroTAK, LLC)
FDA cleared510(k) · K252635FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared the ArthroTAK Tendon Anchor Kit under 510(k) K252635 on May 1, 2026; the company announced it on May 4.
  • The clearance covers soft-tissue to bone fixation in biceps tenodesis shoulder procedures.
  • The 510(k) summary lists bench, sterilization and biocompatibility testing; it marks clinical testing as not applicable.

The US Food and Drug Administration has cleared the ArthroTAK Tendon Anchor Kit, a sutureless implant system for reattaching the biceps tendon to bone, ArthroTAK, LLC said in a May 4 release posted on Orthopedics This Week's press release page.

The FDA's 510(k) database lists the clearance as K252635, a traditional 510(k) received on August 20, 2025, with a substantially equivalent decision on May 1, 2026. The device falls under product code MBI, a nondegradable soft-tissue fixation fastener, and was reviewed by the agency's orthopedic panel. The database lists the applicant at an address in Missoula, Montana; the release describes ArthroTAK as an Orlando-based company.

What the clearance covers

According to the clearance letter and 510(k) summary, the kit "is intended to be used for soft-tissue to bone fixation in biceps tenodesis shoulder procedures." Biceps tenodesis is an operation that detaches the long head of the biceps tendon and fixes it to the upper arm bone.

The summary describes an implant made of polyetheretherketone (PEEK) in two parts, a proximal tack and a distal bullet, which comes pre-loaded on an inserter. A single-use bone punch can be used to make a pilot hole in hard bone. ArthroTAK named Aevumed's PROTEKT Suture Anchor as the primary predicate device and the SnapShot Fixation System as a second predicate, saying the new kit uses the same implant material as the first and shares design features with the second.

Testing listed in the summary includes insertion, pullout, component interconnection, fatigue and pull-to-failure testing, along with sterilization validation and biological evaluation. The clinical testing section is marked "Not Applicable."

The company's pitch to surgery centers

In the release, ArthroTAK said the implant is delivered through the tendon and into bone "in a single, mallet-driven step," then locked by turning the inserter knob clockwise. The company said this removes the need for sutures, suture passers, knot-tying or power equipment.

"Biceps tenodesis is a high-volume sports medicine procedure that has long been dominated by complex, suture-dependent techniques," said Justin J. Kaler, the company's general manager. He said the kit gives ambulatory surgery centers and hospitals "a way to drive efficiency without compromising fixation strength."

The release said the procedure is performed more than 220,000 times a year in the US, with many cases moving from hospital outpatient departments to ambulatory surgery centers. It said benchtop testing showed fixation strength "competitive with leading marketed biceps tenodesis devices"; that is company-reported bench data, not a clinical comparison.

The implant can be used in arthroscopic suprapectoral, arthroscopic high-groove and open subpectoral approaches, and can be placed percutaneously or through a cannula of 8 mm or larger, according to the company.

Next steps

ArthroTAK said the clearance allows it to start commercial distribution in the US through independent distributor partners. It did not give a price or a launch date. The company said the same fixation platform is being evaluated for other sports medicine uses; any new indication would need its own FDA review.

Sources

  1. ArthroTAK Receives FDA 510(k) Clearance for the ArthroTAK Tendon Anchor Kit (company press release, posted on Orthopedics This Week's press release page), ArthroTAK, May 4, 2026
  2. 510(k) K252635: ArthroTAK Tendon Anchor Kit (database record), US Food and Drug Administration, May 1, 2026
  3. K252635 clearance letter and 510(k) summary, US Food and Drug Administration, May 1, 2026