Cleared Traditional

K961608 - SYNTHES (U.S.A.) POLYPIN

K961608 is an FDA 510(k) clearance for SYNTHES (U.S.A.) POLYPIN, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K961608 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K961608

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
Combination Product No
PCCP Authorized No
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.

HTY Device Classification - Class 2, Special Controls

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 159
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K961608.
OSTEO KIRSCHNER WIRES
K971962 · Osteonics Corp. · Aug 1997
SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM
K971783 · Synthes (Usa) · Jul 1997
ORTHOTEC K-CAP SYSTEM
K971453 · Orthotech · Jun 1997
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM
K970733 · Synthes (Usa) · Apr 1997
FIXATION PIN OR ROD
K970036 · United States Surgical, A Division of Tyco Healthc · Mar 1997
BIORIGID NAIL TIBIA
K970013 · Aap GmbH and Co. Betriebs KG · Mar 1997