Cleared Traditional

K950272 - PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM (FDA 510(k) Clearance)

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

K950272 · Ethicon, Inc. · Orthopedic device
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Jan 1996
Decision
360d
Days
Class 2
Risk

K950272 is an FDA 510(k) clearance for the PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM. 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 January 18, 1996 after a review of 360 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 Ethicon, Inc. devices

Submission Details

510(k) Number K950272 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 23, 1995
Decision Date January 18, 1996
Days to Decision 360 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
238d slower than avg
Panel avg: 122d · This submission: 360d
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 230
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