Cleared Traditional

K955553 - PERFECTA REVISION HIP SYSTEM

K955553 is an FDA 510(k) clearance for PERFECTA REVISION HIP SYSTEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K955553 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K955553

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.

LWJ Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K955553.
PLUS EPF ACETABULAR CUP
K972931 · Hhl Consulting · Nov 1997
PLUS-FIT ACETABULAR CUP
K973077 · Plus Orthopedics · Nov 1997
PRESS-FIT HIP STEM
K964178 · Encore Orthopedics, Inc. · May 1997
SC, CEMENTLESS HIP SYSTEM
K962034 · Artos Medical Products GmbH · Oct 1996
CHROME COBALT BALL HEAD
K962268 · Artos Medical Products GmbH · Oct 1996
DELTA HIP PROSTHESIS
K961378 · Zimmer, Inc. · Oct 1996