Cleared Traditional

K935078 - S-ROM TOTAL HIP REPLACEMENT SYSTEM

K935078 is an FDA 510(k) clearance for S-ROM TOTAL HIP REPLACEMENT SYSTEM, manufactured by Joint Medical Products Corp.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K935078 · Joint Medical Products Corp. · Orthopedic device
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Mar 1994
Decision
135d
Days
Class 2
Risk

K935078 is an FDA 510(k) clearance for the S-ROM TOTAL HIP REPLACEMENT SYSTEM. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Joint Medical Products Corp. (Stamford, US). The FDA issued a Cleared decision on March 9, 1994 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Joint Medical Products Corp. devices

FDA 510(k) Submission Details - K935078

510(k) Number K935078 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 25, 1993
Decision Date March 09, 1994
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDG Device Classification - Class 2, Special Controls

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 44
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K935078.
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