BLUE ORTHOCORD SUTURE— 510(k) K043298

Clearance details

Applicant

Depuy Mitek

Product code

Code NEW

Device class

Class 2

Regulation

21 CFR 878.4840

Advisory panel

General, Plastic Surgery

Date received

2004-11-30

Decision date

2004-12-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Norwood, MA, US

• K253879 — MONOFIX PDO2026-08-25
• K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture2026-07-09
• K252171 — Barbed PDO Suture2026-06-12
• K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices2026-05-18
• K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture2025-11-12

• K243790 — GRYPHON X Anchor; HEALIX TRANSTEND Anchor2025-02-05
• K241010 — HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors2024-09-11
• K240441 — MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw2024-03-15
• K143475 — VAPR Tripolar Suction Electrode2015-04-03
• K120449 — HEALIX ADVANCE PEEK ANCHOR2012-05-11

Death

32

Injury

2,179

Malfunction

8,975

Total

11,186

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-1172-2013 — ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.Class II·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·20130322
• Z-1173-2013 — ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.Class II·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·20130322
• Z-1174-2013 — ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.Class II·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·20130322
• Z-1175-2013 — ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.Class II·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·20130322
• Z-1176-2013 — ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.Class II·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·20130322

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043298.