Cleared Traditional

K950070 - MITEK TOGGLE ANCHOR(TM)

K950070 is an FDA 510(k) clearance for MITEK TOGGLE ANCHOR(TM), manufactured by Mitek Surgical Products, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K950070 · Mitek Surgical Products, Inc. · Orthopedic device
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May 1995
Decision
133d
Days
Class 2
Risk

K950070 is an FDA 510(k) clearance for the MITEK TOGGLE ANCHOR(TM). Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Mitek Surgical Products, Inc. (Westwood, US). The FDA issued a Cleared decision on May 22, 1995 after a review of 133 days - within the typical 510(k) review window.

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 Mitek Surgical Products, Inc. devices

FDA 510(k) Submission Details - K950070

510(k) Number K950070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1995
Decision Date May 22, 1995
Days to Decision 133 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 122d · This submission: 133d
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 197
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K950070.
HOWMEDICA MAINSTAY ANCHOR
K953531 · Howmedica Corp. · Sep 1995
LMT BONE ANCHOR
K953764 · Li Medical Technologies, Inc. · Aug 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
K943950 · Ethicon, 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
BIOABSORBABLE INTERFERENCE SCREW
K943548 · Acufex Microsurgical, Inc. · Mar 1995