Cleared Traditional

K922733 - PERFECTA TOTAL HIP SYSTEM AND PROFORMA ...

K922733 is an FDA 510(k) clearance for PERFECTA TOTAL HIP SYSTEM AND PROFORMA ..., manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K922733 · Orthomet, Inc. · Orthopedic device
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Feb 1993
Decision
246d
Days
Class 2
Risk

K922733 is an FDA 510(k) clearance for the PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 9, 1993 after a review of 246 days - an extended review 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: 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 - K922733

510(k) Number K922733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1992
Decision Date February 09, 1993
Days to Decision 246 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
124d slower than avg
Panel avg: 122d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

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 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K922733.
PERFECTA TOTAL HIP SYSTEM
K922847 · Orthomet, Inc. · Apr 1993
TECHMEDICA CAD/CAM CUSTOM HIP
K911058 · Techmedica, Inc. · Feb 1993
THE UNIVERSAL BONE CEMENT RESISTOR
K924323 · Biodynamic Technologies, Inc. · Feb 1993
DEPUY HIP PROSTHESIS
K914078 · Depuy, Inc. · Jan 1993
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K920739 · Joint Medical Products Corp. · Nov 1992
C-FIT CEMENTED HIP STEM
K923898 · Turnkey Intergration USA, Inc. · Nov 1992