Cleared Traditional

OGDEN ANCHOR-SMALL (TENTATIVE) (K941029) - FDA 510(k) Clearance

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

K941029 · American Medical Electronics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
339d
Days
Class 2
Risk

K941029 is an FDA 510(k) clearance for the OGDEN ANCHOR-SMALL (TENTATIVE). 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 February 9, 1995 after a review of 339 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 American Medical Electronics, Inc. devices

Submission Details

510(k) Number K941029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date February 09, 1995
Days to Decision 339 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
217d slower than avg
Panel avg: 122d · This submission: 339d
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 K941029.
PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
K950272 · Ethicon, Inc. · Jan 1996
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