Cleared Traditional

PERFECTA II/NON-COATED TOTAL HIP SYSTEM (K884027) - FDA 510(k) Clearance

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

K884027 · Orthomet, Inc. · Orthopedic device
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Apr 1989
Decision
196d
Days
Class 2
Risk

K884027 is an FDA 510(k) clearance for the PERFECTA II/NON-COATED 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 April 7, 1989 after a review of 196 days - an extended review 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: 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 Orthomet, Inc. devices

Submission Details

510(k) Number K884027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1988
Decision Date April 07, 1989
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
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 K884027.
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
K894149 · Howmedica Corp. · Sep 1989
MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL
K894148 · Howmedica Corp. · Sep 1989
EXETER II TOTAL HIP SYSTEM
K891454 · Howmedica Corp. · Jun 1989
AML BOWED FEMORAL HIP
K885338 · Depuy, Inc. · Mar 1989
OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST.
K890649 · Osteonics Corp. · Mar 1989
GEMINI FEMORAL HIP PROSTHESIS
K883724 · Depuy, Inc. · Nov 1988