ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS— 510(k) K122059

Clearance details

Applicant

Smith & Nephew, Inc.

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2012-07-13

Decision date

2013-03-18

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-2746-2020 — SUTUREFIX ULTRA Suture, Product number 72203855Class II·Ongoing·Smith & Nephew, Inc.·20200624
• Z-2045-2014 — SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissueClass II·Terminated·Smith & Nephew, Inc. Endoscopy Division·20140602
• Z-2046-2014 — SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissueClass II·Terminated·Smith & Nephew, Inc. Endoscopy Division·20140602
• Z-2047-2014 — SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissueClass II·Terminated·Smith & Nephew, Inc. Endoscopy Division·20140602
• Z-2048-2014 — SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissueClass II·Terminated·Smith & Nephew, Inc. Endoscopy Division·20140602
• Z-2049-2014 — SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissueClass II·Terminated·Smith & Nephew, Inc. Endoscopy Division·20140602

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122059.