Cleared Traditional

K961719 - EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES

K961719 is an FDA 510(k) clearance for EPITEC TITANIUM IMPLANT SYSTEM FOR THE ..., manufactured by Howmedica Leibinger, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K961719 · Howmedica Leibinger, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
441d
Days
Class 2
Risk

K961719 is an FDA 510(k) clearance for the EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Howmedica Leibinger, Inc. (Dallas, US). The FDA issued a Cleared decision on July 17, 1997 after a review of 441 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Howmedica Leibinger, Inc. devices

FDA 510(k) Submission Details - K961719

510(k) Number K961719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1996
Decision Date July 17, 1997
Days to Decision 441 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
319d slower than avg
Panel avg: 122d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 1075
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K961719.
OSTEO ANATOMICAL BONE PLATES
K972196 · Osteonics Corp. · Aug 1997
LACTOSORB TRAUMA PLATING SYSTEM
K971870 · Biomet, Inc. · Aug 1997
LORENZ PECTUS SUPPORT BAR
K972420 · Walter Lorenz Surgical, Inc. · Aug 1997
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K971321 · Osteonics Corp. · Jul 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES
K970258 · Ferguson Medical · May 1997
CENTRE-DRIVE DRILL-FREE SCREW
K971297 · KLS-Martin L.P. · May 1997