Cleared Traditional

K884027 - PERFECTA II/NON-COATED TOTAL HIP SYSTEM

K884027 is an FDA 510(k) clearance for PERFECTA II/NON-COATED TOTAL HIP SYSTEM, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 196-day FDA review.

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

FDA 510(k) Submission Details - K884027

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
Combination Product No
PCCP Authorized No
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.

JDI Device Classification - Class 2, Special Controls

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 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K884027.
APR COLLARED REVISION FEMORAL COMPONENT
K885192 · Intermedics Orthopedics · Jun 1989
EXETER II TOTAL HIP SYSTEM
K891454 · Howmedica Corp. · Jun 1989
INTRAFORM TOTAL HIP SYSTEM
K890742 · Orthomet, Inc. · May 1989
AML BOWED FEMORAL HIP
K885338 · Depuy, Inc. · Mar 1989
OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST.
K890649 · Osteonics Corp. · Mar 1989
M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.
K890054 · Protek, Inc. · Feb 1989