Cleared Traditional

K930538 - ACUFEX SURETAC(R) PAC

K930538 is an FDA 510(k) clearance for ACUFEX SURETAC PAC, 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 223-day FDA review.

K930538 · Acufex Microsurgical, Inc. · Orthopedic device
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Sep 1993
Decision
223d
Days
Class 2
Risk

K930538 is an FDA 510(k) clearance for the ACUFEX SURETAC(R) PAC. 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 September 13, 1993 after a review of 223 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K930538

510(k) Number K930538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1993
Decision Date September 13, 1993
Days to Decision 223 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
101d slower than avg
Panel avg: 122d · This submission: 223d
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 K930538.
MITEK SUPER QUICKANCHOR, MODIFICATION
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STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
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MITEK LIGAMENT ANCHOR
K926270 · Mitek Surgical Products, Inc. · Oct 1993
MINVASIVE SUTURE BONE FASTENER
K924034 · Innovasive Devices, Inc. · Aug 1993
ACUFEX(R) TAG(TM)
K911293 · Acufex Microsurgical, Inc. · Jul 1993
CONCEPT 4MM CANCELLOUS SCREW WITH EYELET
K924941 · Linvatec Corp. · Jun 1993