Cleared Traditional

K920969 - HYDROXYLAPATITE INFINITY

K920969 is an FDA 510(k) clearance for HYDROXYLAPATITE INFINITY, manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 429-day FDA review.

K920969 · Dow Corning Wright · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K920969

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
Combination Product No
PCCP Authorized No
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.

MEH Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K920969.
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
H-220 PRESS-FIT ACETABULAR CUP SYSTEM
K926134 · Implex Corp. · Oct 1993
PERFECTA TOTAL HIP SYSTEM, HA COATED
K915190 · Orthomet, Inc. · Dec 1992
INTER-HA HIP PROSTHESIS
K921672 · Kirschner Medical Corp. · Aug 1992
KINAMED ATH-HA & ATH-HA LONG TOTAL HIP
K914843 · Kinamed, Inc. · Feb 1992