CinchLock Flex Knotless Suture Anchor— 510(k) K151314

Clearance details

Applicant

Pivot Medical

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2015-05-18

Decision date

2015-07-23

Decision

Substantially Equivalent

Clearance type

Special

Location

Sunnyvale, CA, US

• K253065 — Aevumed SUPERCYNCH Button System2026-09-02
• K262809 — ArthroTAK Tendon Anchor Kit2026-09-02
• K262677 — Iconix Knotless T2026-08-27
• K262047 — Grappler Suture Anchor System2026-08-03
• K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

• K123651 — CINCHLOCK KNOTLESS SUTURE ANCHOR2013-02-21
• K110473 — NANOTACK SUTURE ANCHOR 1.4MM2011-05-25

Injury

3,163

Malfunction

13,006

Other

2

Total

16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1328-2025 — Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197Class II·Ongoing·Stryker Corporation·20250129
• Z-1635-2016 — CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.Class II·Terminated·Stryker Corporation·20160412

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151314.