510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K141711Substantially Equivalent

Pontis 3Mm Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis Ultra-High Molecular Weight Polye

Pontis Orthopaeeics, LLC, San Francisco CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141711 is the FDA 510(k) clearance record for PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE, a class II device, cleared for Pontis Orthopaeeics, LLC on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list one 510(k) clearance for Pontis Orthopaeeics, LLC. As of , FDA records show no recalls naming K141711.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Pontis Orthopaeeics, LLC 2299 Post St., Suite 103, San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBI

Trailing 12 months
31 clearances under product code MBI in the twelve months to October 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20260