SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR— 510(k) K100159

Clearance details

Applicant

Smith & Nephew Inc., Endoscopy Div.

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2010-01-20

Decision date

2010-04-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Andover, MA, US

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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-2165-2012 — Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618Class II·Terminated·Smith & Nephew, Inc. Endoscopy Division·20120703
• Z-2166-2012 — Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to boneClass II·Terminated·Smith & Nephew, Inc. Endoscopy Division·20120703
• Z-2167-2012 — Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to boneClass II·Terminated·Smith & Nephew, Inc. Endoscopy Division·20120703
• Z-2168-2012 — Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to boneClass II·Terminated·Smith & Nephew, Inc. Endoscopy Division·20120703

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100159.