Cleared Traditional

K961608 - SYNTHES (U.S.A.) POLYPIN (FDA 510(k) Clearance)

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

K961608 · Synthes (Usa) · Orthopedic device
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May 1997
Decision
379d
Days
Class 2
Risk

K961608 is an FDA 510(k) clearance for the SYNTHES (U.S.A.) POLYPIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K961608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1996
Decision Date May 09, 1997
Days to Decision 379 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
257d slower than avg
Panel avg: 122d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 203
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