Cleared Traditional

K971783 - SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM

K971783 is an FDA 510(k) clearance for SYNTHES ELASTIC INTRAMEDULLARY NAIL (EI..., 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 65-day FDA review.

K971783 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
65d
Days
Class 2
Risk

K971783 is an FDA 510(k) clearance for the SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM. 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 July 18, 1997 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K971783

510(k) Number K971783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1997
Decision Date July 18, 1997
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 K971783.
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974291 · Mitek Products · Mar 1998
SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION
K973240 · Synthes (Usa) · Nov 1997
OSTEO KIRSCHNER WIRES
K971962 · Osteonics Corp. · Aug 1997
ORTHOTEC K-CAP SYSTEM
K971453 · Orthotech · Jun 1997
SYNTHES (U.S.A.) POLYPIN
K961608 · Synthes (Usa) · May 1997
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM
K970733 · Synthes (Usa) · Apr 1997