Cleared Traditional

HYDROXYLAPATITE INFINITY(R) (K920969) - FDA 510(k) Clearance

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

K920969 · Dow Corning Wright · Orthopedic device
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May 1993
Decision
429d
Days
Class 2
Risk

K920969 is an FDA 510(k) clearance for the HYDROXYLAPATITE INFINITY(R). Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on May 5, 1993 after a review of 429 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Dow Corning Wright devices

Submission Details

510(k) Number K920969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date May 05, 1993
Days to Decision 429 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
307d slower than avg
Panel avg: 122d · This submission: 429d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 103
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K920969.
STABILITY FEMORAL PROSTHESIS W/HAP
K915655 · Depuy, Inc. · Feb 1994
HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE
K925607 · Zimmer, Inc. · Nov 1993
CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING
K926299 · Depuy, Inc. · Oct 1993
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
K912369 · Biomet, Inc. · Oct 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370 · Biomet, Inc. · Oct 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
K912263 · Zimmer, Inc. · Aug 1991