Cleared Traditional

K931519 - ACUFEX SURETAC

K931519 is an FDA 510(k) clearance for ACUFEX SURETAC, manufactured by Acufex Microsurgical, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 447-day FDA review.

K931519 · Acufex Microsurgical, Inc. · Orthopedic device
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Jun 1994
Decision
447d
Days
Class 2
Risk

K931519 is an FDA 510(k) clearance for the ACUFEX SURETAC. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on June 16, 1994 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K931519

510(k) Number K931519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1993
Decision Date June 16, 1994
Days to Decision 447 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
325d slower than avg
Panel avg: 122d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDR Staple, Fixation, Bone

All 190
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K931519.
INNOVASIVE SUTURE BONE FASTENER WITH SUTURE
K935321 · Innovasive Devices, Inc. · Oct 1994
MITEK GIII ANCHOR
K931782 · Mitek Surgical Products, Inc. · Jul 1994
QUICKANCHOR II
K931253 · Mitek Surgical Products, Inc. · Jun 1994
MITEK MINI ANCHOR, MODIFICATION
K930892 · Mitek Surgical Products, Inc. · Jan 1994
MITEK SUPER QUICKANCHOR, MODIFICATION
K930893 · Mitek Surgical Products, Inc. · Dec 1993
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · Zimmer, Inc. · Nov 1993