Cleared Traditional

PROFORMA/PS TOTAL HIP SYSTEM (K880435) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 282
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K880435.
GEMINI FEMORAL HIP PROSTHESIS
K883724 · Depuy, Inc. · Nov 1988
FOCUS TOTAL HIP SYSTEM
K883460 · Depuy, Inc. · Oct 1988
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM
K882812 · Osteonics Corp. · Aug 1988
LCS FEMORAL HIP PROSTHESIS
K880269 · Depuy, Inc. · May 1988
TITANIUM FEMORAL HIP
K881128 · Depuy, Inc. · Mar 1988
ANATOMIC TOTAL HIP
K874229 · Zimmer, Inc. · Nov 1987