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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Distalmotion's Dexter Robot for Sacrocolpopexy in Second Gynecology Expansion

The 510(k) adds pelvic organ prolapse repair to the outpatient-focused robot's US label, backed by a 35-patient study.

By News DeskJune 17, 20262 min read
Dexter robotic surgery system in an operating room with a surgeon working
The Dexter surgical robot in use in an operating room, from Distalmotion's release announcing the clearance. Photo: Distalmotion · Company press image published with the release on Distalmotion's newsroom
FDA cleared510(k) · K260653FDA 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 Distalmotion's Dexter L6 System for sacrocolpopexy under 510(k) K260653 on June 11, 2026; the company announced it on June 16.
  • Distalmotion described the clearance as covering sacrocolpopexy, sacrocervicopexy, sacrohysteropexy and endometriosis resection; the indications statement in the FDA clearance adds sacrocolpopexy to the label.
  • In the 35-patient SPARO study, 34 procedures were completed robotically and three patients had serious complications, all resolved by 42 days, according to the 510(k) summary.

Distalmotion has received US Food and Drug Administration 510(k) clearance to market its Dexter robotic surgery system for further gynecologic procedures, the Swiss company said in a June 16 release. It is Dexter's second US clearance in gynecology and its fourth overall.

The FDA's 510(k) database lists the clearance as K260653 for the Dexter L6 System, received on February 27, 2026, with a substantially equivalent decision on June 11, 2026. The predicate was the company's own Dexter L6 System cleared under K251197.

What the label now covers

Distalmotion said the clearance covers sacrocolpopexy, sacrocervicopexy and sacrohysteropexy, three reconstructive procedures for pelvic organ prolapse, as well as endometriosis resection. The indications for use statement in the FDA clearance letter and 510(k) summary names one new procedure: Dexter is intended for use in laparoscopic inguinal hernia repair, cholecystectomy, total benign hysterectomy including salpingo-oophorectomy, and sacrocolpopexy, in adults aged 22 and older. The company's own US indications statement at the foot of its release uses the same wording.

According to the summary, the device itself has not changed since the earlier clearance; only the labeling was revised to address use in sacrocolpopexy, and earlier bench testing was carried over.

The SPARO study

The clearance was supported by SPARO, a prospective, multicenter, open-label study of Dexter in robotic-assisted laparoscopic sacrocolpopexy or sacrocervicopexy. It included 35 patients with a mean age of 65. The primary performance endpoint, completing the procedure without converting to open or fully laparoscopic surgery, was met in 34 of 35 procedures (97.1%), and no conversions to open surgery were recorded.

For the primary safety endpoint, three patients (8.6%) had Clavien-Dindo grade III to V events within 42 days: a hematoma and a lower leg compartment syndrome that each required reoperation, and a genitourinary tract infection that required rehospitalization. All three had resolved by the 42-day visit, the summary states.

Outpatient strategy

Distalmotion, based in Lausanne with a US office in Cleveland, is aiming Dexter at ambulatory surgery centers and other outpatient sites, where it says the added procedures let administrators expand gynecology service lines and raise system use. Its compact, portable design distinguishes it from Intuitive's da Vinci system, a mainstay in many US hospitals, MedTech Dive reported.

"Securing FDA clearance for these additional GYN indications is another important milestone for the DEXTER program," said chief executive Greg Roche. Dexter's earlier US clearances cover hysterectomy with salpingo-oophorectomy, inguinal hernia repair and gallbladder removal. The company said it is running a US investigational device exemption study of Dexter in myomectomy, the removal of uterine fibroids, and that more than 4,000 patients have been treated with the system, a company-reported figure.

Sources

  1. Distalmotion Supports ASCs in Expanding GYN Service Lines with US FDA 510(k) Clearance for Additional Gynecology Indications, Distalmotion, June 16, 2026
  2. 510(k) K260653: Dexter L6 System (database record), US Food and Drug Administration, June 11, 2026
  3. K260653 clearance letter and 510(k) summary, US Food and Drug Administration, June 11, 2026
  4. Distalmotion, in US push, adds more robotic gynecology indications, MedTech Dive, June 17, 2026