Cleared Traditional

K972641 - DUAL OFFSET PERFECTA IMC HIP STEM

K972641 is the FDA 510(k) clearance for DUAL OFFSET PERFECTA IMC HIP STEM by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K972641 · Wrightmedicaltechnologyinc · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 1997
Decision
86d
Days
Class 2
Risk

K972641 is an FDA 510(k) clearance for the DUAL OFFSET PERFECTA IMC HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on October 9, 1997 after a review of 86 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K972641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1997
Decision Date October 09, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K972641.
STELKAST BIPOLAR SYSTEM
K972961 · Stelkast Company · Nov 1997
KERBOULL CROSS
K972928 · Howmedica, Inc. · Nov 1997
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
K972792 · Howmedica Corp. · Oct 1997
OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)
K972460 · Osteonics Corp. · Sep 1997
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
K972435 · Johnson & Johnson Professionals, Inc. · Sep 1997
RECOVERY PROTRUSIO CAGE
K971890 · Biomet, Inc. · Aug 1997