Cleared Traditional

OGDEN ANCHOR ADDITIONAL APPLICATIONS (K935065) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 66
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K935065.
HOWMEDICA MAINSTAY ANCHOR
K953531 · Howmedica Corp. · Sep 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
K943950 · Ethicon, Inc. · May 1995
ARTHREX STAPLES
K943492 · Arthrex, Inc. · Feb 1995
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · Zimmer, Inc. · Nov 1993
HARPOON SUTURE ANCHOR
K926037 · Biomet, Inc. · May 1993
BONE STAPLE(S)
K904553 · Synthes (Usa) · Dec 1990