PEBA ANCHOR/SUTURE COMBINATION— 510(k) K972326

Clearance details

Applicant

Orthopaedic Biosystems, Ltd.

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

1997-06-23

Decision date

1998-02-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Scotsdale, AZ, US

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• 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

• K000797 — OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-012000-04-03
• K982996 — POLYMER OBL SB ANCHOR / SUTURE COMBINATION1999-03-04
• K983169 — POLYMER THREADED ANCHOR1998-12-16
• K982963 — POLYMER THREADED ANCHOR / SUTURE COMBINATION1998-11-20
• K963420 — CANCELLOUS SCREW WASHER1996-11-15

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-1273-2020 — TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.Class II·Terminated·Smith & Nephew, Inc.·20191230

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972326.