Cleared Traditional

K935065 - OGDEN ANCHOR ADDITIONAL APPLICATIONS

K935065 is an FDA 510(k) clearance for OGDEN ANCHOR ADDITIONAL APPLICATIONS, manufactured by American Medical Electronics, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 467-day FDA review.

K935065 · American Medical Electronics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 1995
Decision
467d
Days
Class 2
Risk

K935065 is an FDA 510(k) clearance for the OGDEN ANCHOR ADDITIONAL APPLICATIONS. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by American Medical Electronics, Inc. (Richardson, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 467 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 American Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K935065

510(k) Number K935065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date January 30, 1995
Days to Decision 467 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
345d slower than avg
Panel avg: 122d · This submission: 467d
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 208
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K935065.
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
BONE ANCHOR
K942787 · Acu Med, Inc. · Dec 1994
INNOVASIVE SUTURE BONE FASTENER WITH SUTURE
K935321 · Innovasive Devices, Inc. · Oct 1994
MITEK GIII ANCHOR
K931782 · Mitek Surgical Products, Inc. · Jul 1994