Cleared Traditional

K921836 - PERFECTA TOTAL HIP SYSTEM

K921836 is an FDA 510(k) clearance for 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 203-day FDA review.

K921836 · Orthomet, Inc. · Orthopedic device
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Nov 1992
Decision
203d
Days
Class 2
Risk

K921836 is an FDA 510(k) clearance for the PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD. 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 November 6, 1992 after a review of 203 days - an extended review cycle.

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 - K921836

510(k) Number K921836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date November 06, 1992
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 122d · This submission: 203d
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 K921836.
OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K925695 · Osteonics Corp. · Apr 1993
CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION
K925512 · Dow Corning Wright · Feb 1993
ORTHOMET PERFECTA TOTAL HIP SYSTEM
K923583 · Orthomet, Inc. · Dec 1992
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
K915641 · Biomet, Inc. · Nov 1992
KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL
K920290 · Kinamed, Inc. · Nov 1992
KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL
K920219 · Kinamed, Inc. · Oct 1992