Cleared Traditional

K970400 - BONE SOURCE HYDROXYAPATITE

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

K970400 · Orthofix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K970400

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.

LZK Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K970400.
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502 · Implantech Associates, Inc. · Nov 1997
DURALASTIC ANATOMICAL MALAR IMPLANT
K973574 · Hanson Medical, Inc. · Oct 1997
DURALASTIC ANATOMICAL MALAR IMPLANTS
K971479 · Allied Biomedical Corp. · Jul 1997
SURGIFORM ANATOMICAL MALAR
K964443 · Surgical Technology Laboratories, Inc. · Dec 1996
IMPLANTECH WM NASAL-LABIAL IMPLANT
K962261 · Implantech Associates, Inc. · Aug 1996
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K961511 · Lifecore Biomedical, Inc. · Jun 1996