Cleared Traditional

PERFECTA REVISION HIP SYSTEM (K955553) - FDA 510(k) Clearance

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

K955553 · Wrightmedicaltechnologyinc · Orthopedic device
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Oct 1996
Decision
324d
Days
Class 2
Risk

K955553 is an FDA 510(k) clearance for the PERFECTA REVISION HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on October 24, 1996 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K955553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date October 24, 1996
Days to Decision 324 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
202d slower than avg
Panel avg: 122d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 24
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K955553.
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
K002141 · Exactech, Inc. · Aug 2000
HOWMEDICA OSTEONICS FEMORAL HEADS
K993601 · Howmedica Osteonics Corp. · Nov 1999
OSTEONICS EXTENDED FEMORAL BEARING HEAD
K982936 · Osteonics Corp. · Oct 1998
DELTA HIP PROSTHESIS
K961378 · Zimmer, Inc. · Oct 1996
LFIC OR FETTO HIP
K952776 · Zimmer, Inc. · Feb 1996
HOWMEDICA V40 22MM FEMORAL HEAD
K950541 · Howmedica Corp. · Mar 1995