Cleared Traditional

K970675 - HEADLOC CERAMIC HEAD

K970675 is an FDA 510(k) clearance for HEADLOC CERAMIC HEAD, manufactured by Ortho Development Corp.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 179-day FDA review.

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

FDA 510(k) Submission Details - K970675

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
Combination Product No
PCCP Authorized No
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.

LZO Device Classification - Class 2, Special Controls

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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K970675.
ZIRCONIA CERAMIC FEMORAL HEAD
K972690 · Zimmer, Inc. · Oct 1997
PRECEDENT REVISION HIP SYSTEM
K972637 · Sulzer Orthopedics, Inc. · Oct 1997
V40 ZIRCONIA FEMORAL HEADS
K972361 · Howmedica, Inc. · Sep 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