Cleared Traditional

K943548 - BIOABSORBABLE INTERFERENCE SCREW

K943548 is an FDA 510(k) clearance for BIOABSORBABLE INTERFERENCE SCREW, 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 242-day FDA review.

K943548 · Acufex Microsurgical, Inc. · Orthopedic device
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Mar 1995
Decision
242d
Days
Class 2
Risk

K943548 is an FDA 510(k) clearance for the BIOABSORBABLE INTERFERENCE SCREW. 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 March 20, 1995 after a review of 242 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 - K943548

510(k) Number K943548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1994
Decision Date March 20, 1995
Days to Decision 242 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
120d slower than avg
Panel avg: 122d · This submission: 242d
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 K943548.
MITEK TOGGLE ANCHOR(TM)
K950070 · Mitek Surgical Products, Inc. · May 1995
ACUFEX TAG(R) BIOABSORBABLE ANCHORS
K946346 · Acufex Microsurgical, Inc. · Apr 1995
MITEK G III ANCHOR, MITEK LS ANCHOR
K944936 · Mitek Surgical Products, Inc. · Mar 1995
MITEK THRADED ANCHOR (MTA)
K945203 · Mitek Surgical Products, Inc. · Mar 1995
ACUFEX TAG ANCHOR
K934867 · Acufex Microsurgical, Inc. · Feb 1995
ARTHREX STAPLES
K943492 · Arthrex, Inc. · Feb 1995