Cleared Traditional

HEADLOC CERAMIC HEAD (K970675) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970675 · Ortho Development Corp. · Orthopedic device
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Aug 1997
Decision
179d
Days
Class 2
Risk

K970675 is an FDA 510(k) clearance for the HEADLOC CERAMIC HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on August 22, 1997 after a review of 179 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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. Standard predicate reliance. 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 Ortho Development Corp. devices

Submission Details

510(k) Number K970675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date August 22, 1997
Days to Decision 179 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 122d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K970675.
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K973307 · Johnson & Johnson Professionals, Inc. · Nov 1997
PARTNERSHIP REVISION FEMORAL STEMS
K972893 · Howmedica Corp. · Nov 1997
ZIRCONIA CERAMIC FEMORAL HEAD
K972690 · Zimmer, Inc. · Oct 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
K964431 · Biomet, Inc. · Aug 1997
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
K971752 · Zimmer, Inc. · Jul 1997
OSTEONICS ANTEVERTED NECK HIP STEM
K971497 · Osteonics Corp. · Jul 1997