Cleared Traditional

K880435 - PROFORMA/PS TOTAL HIP SYSTEM

K880435 is an FDA 510(k) clearance for PROFORMA/PS TOTAL HIP SYSTEM, 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 148-day FDA review.

K880435 · Orthomet, Inc. · Orthopedic device
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Jun 1988
Decision
148d
Days
Class 2
Risk

K880435 is an FDA 510(k) clearance for the PROFORMA/PS TOTAL HIP SYSTEM. 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 June 29, 1988 after a review of 148 days - within the typical 510(k) review window.

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 - K880435

510(k) Number K880435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1988
Decision Date June 29, 1988
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
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 K880435.
FOCUS TOTAL HIP SYSTEM
K883460 · Depuy, Inc. · Oct 1988
BIOPRO PC FEMORAL HIP COMPONENT
K882146 · Biopro, Inc. · Aug 1988
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM
K882812 · Osteonics Corp. · Aug 1988
HJD CALCAR REPLACEMENT PROSTHESIS
K881769 · Richards Medical Co., Inc. · Jun 1988
LCS FEMORAL HIP PROSTHESIS
K880269 · Depuy, Inc. · May 1988
RESUBMITTING OF HJD TOTAL HIP SYSTEM
K881117 · Richards Medical Co., Inc. · Apr 1988