Cleared Traditional

K970400 - BONE SOURCE HYDROXYAPATITE

K970400 is the FDA 510(k) clearance for BONE SOURCE HYDROXYAPATITE by Orthofix, Inc.. It is a Class 2 General & Plastic Surgery device (product code LZK) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K970400 · Orthofix, Inc. · General & Plastic Surgery device
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May 1997
Decision
88d
Days
Class 2
Risk

K970400 is an FDA 510(k) clearance for the BONE SOURCE HYDROXYAPATITE. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Orthofix, Inc. (Richardson, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3550 - the FDA general and plastic surgery device 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 Orthofix, Inc. devices

Submission Details

510(k) Number K970400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date May 02, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZK Implant, Malar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3550
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LZK Implant, Malar

All 13
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K970400.
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
K002886 · Implantech Associates, Inc. · Nov 2000
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502 · Implantech Associates, Inc. · Nov 1997
IMPLANTECH WM NASAL-LABIAL IMPLANT
K962261 · Implantech Associates, Inc. · Aug 1996
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K961511 · Lifecore Biomedical, Inc. · Jun 1996
SAM FACIAL IMPLANT
K961210 · W.L. Gore & Associates, Inc. · Jun 1996
IMPLANTECH NASAL LABIAL IMPLANT
K943988 · Implantech Associates, Inc. · Jan 1995