Cleared Traditional

K915190 - PERFECTA TOTAL HIP SYSTEM

K915190 is an FDA 510(k) clearance for PERFECTA TOTAL HIP SYSTEM, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 398-day FDA review.

K915190 · Orthomet, Inc. · Orthopedic device
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Dec 1992
Decision
398d
Days
Class 2
Risk

K915190 is an FDA 510(k) clearance for the PERFECTA TOTAL HIP SYSTEM, HA COATED. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 24, 1992 after a review of 398 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Orthomet, Inc. devices

FDA 510(k) Submission Details - K915190

510(k) Number K915190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date December 24, 1992
Days to Decision 398 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
276d slower than avg
Panel avg: 122d · This submission: 398d
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 134
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K915190.
CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING
K926299 · Depuy, Inc. · Oct 1993
H-220 PRESS-FIT ACETABULAR CUP SYSTEM
K926134 · Implex Corp. · Oct 1993
HYDROXYLAPATITE INFINITY(R)
K920969 · Dow Corning Wright · May 1993
INTER-HA HIP PROSTHESIS
K921672 · Kirschner Medical Corp. · Aug 1992
KINAMED ATH-HA & ATH-HA LONG TOTAL HIP
K914843 · Kinamed, Inc. · Feb 1992
HYDROXYAPATITE INFINITY TROCHANTERIC MODULE
K915350 · Dow Corning Wright · Feb 1992