Cleared Traditional

K943950 - ETHICON NONABSORBABLE SUTURE ANCHOR

K943950 is an FDA 510(k) clearance for ETHICON NONABSORBABLE SUTURE ANCHOR, manufactured by Ethicon, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K943950 · Ethicon, Inc. · Orthopedic device
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May 1995
Decision
288d
Days
Class 2
Risk

K943950 is an FDA 510(k) clearance for the ETHICON NONABSORBABLE SUTURE ANCHOR. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 288 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 Ethicon, Inc. devices

FDA 510(k) Submission Details - K943950

510(k) Number K943950 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 15, 1994
Decision Date May 30, 1995
Days to Decision 288 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 122d · This submission: 288d
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 130
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K943950.
PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
K950272 · Ethicon, Inc. · Jan 1996
ACUFEX TAG DELIVERY SYSTEM
K953276 · Acufex Microsurgical, Inc. · Oct 1995
HOWMEDICA MAINSTAY ANCHOR
K953531 · Howmedica Corp. · Sep 1995
MITEK TOGGLE ANCHOR(TM)
K950070 · Mitek Surgical Products, 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