Cleared Traditional

PERFECTA TOTAL HIP SYSTEM (K903635) - FDA 510(k) Clearance

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

K903635 · Orthomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
88d
Days
Class 2
Risk

K903635 is an FDA 510(k) clearance for the PERFECTA TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 9, 1990 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthomet, Inc. devices

Submission Details

510(k) Number K903635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date November 09, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 282
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K903635.
OSTEONICS HIP REVISION WEDGES
K905406 · Osteonics Corp. · Jan 1991
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES
K904844 · Howmedica Corp. · Dec 1990
PROXIMAL FEMUR REPLACEMENT STEM
K904919 · Depuy, Inc. · Dec 1990
OSTEONICS DRM ACETABULAR COMPONENT
K903636 · Osteonics Corp. · Oct 1990
OSTEOLOCK(TM) ACETABULAR CUP
K903362 · Howmedica Corp. · Oct 1990
FOCUS COBALT CHROMIUM TOTAL HIP
K904351 · Depuy, Inc. · Oct 1990