Cleared Traditional

K935167 - OGDEN ANCHOR (MODIFICATION)

K935167 is an FDA 510(k) clearance for OGDEN ANCHOR (MODIFICATION), 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 258-day FDA review.

K935167 · American Medical Electronics, Inc. · Orthopedic device
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Jul 1994
Decision
258d
Days
Class 2
Risk

K935167 is an FDA 510(k) clearance for the OGDEN ANCHOR (MODIFICATION). 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 July 12, 1994 after a review of 258 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 American Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K935167

510(k) Number K935167 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 27, 1993
Decision Date July 12, 1994
Days to Decision 258 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 122d · This submission: 258d
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 K935167.
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
QUICKANCHOR II
K931253 · Mitek Surgical Products, Inc. · Jun 1994
ACUFEX SURETAC
K931519 · Acufex Microsurgical, Inc. · Jun 1994
MITEK MINI ANCHOR, MODIFICATION
K930892 · Mitek Surgical Products, Inc. · Jan 1994