BIORAPTOR 2.3 PK SUTURE ANCHOR— 510(k) K071586

Clearance details

Applicant

Smith & Nephew Inc., Endoscopy Division

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2007-06-11

Decision date

2007-08-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Andover, MA, US

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• 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

• K121904 — GYNECOLOGY STERILIZATION TRAY2013-03-11
• K102982 — ENDOBUTTON DIRECT2011-01-05
• K082215 — OSTEORAPTOR SUTURE ANCHOR2008-11-03
• K081098 — ENDOBUTTON CONTINUOUS LOOP (CL)2008-07-16
• K072785 — TWINFIX FT PK2007-12-10

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-0581-2025 — BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.Class II·Ongoing·Smith & Nephew Inc.·20241029

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071586.