Cleared Traditional

K923583 - ORTHOMET PERFECTA TOTAL HIP SYSTEM

K923583 is an FDA 510(k) clearance for ORTHOMET PERFECTA TOTAL HIP SYSTEM, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K923583 · Orthomet, Inc. · Orthopedic device
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Dec 1992
Decision
140d
Days
Class 2
Risk

K923583 is an FDA 510(k) clearance for the ORTHOMET PERFECTA TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 - K923583

510(k) Number K923583 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 20, 1992
Decision Date December 07, 1992
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K923583.
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K920290 · Kinamed, Inc. · Nov 1992