Cleared Traditional

K935012 - BIOMETRIC TOTAL HIP SYSTEM

K935012 is an FDA 510(k) clearance for BIOMETRIC TOTAL HIP SYSTEM, manufactured by Osteo-Technology Intl., Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K935012 · Osteo-Technology Intl., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
138d
Days
Class 2
Risk

K935012 is an FDA 510(k) clearance for the BIOMETRIC TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteo-Technology Intl., Inc. (Timonium, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 138 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 Osteo-Technology Intl., Inc. devices

FDA 510(k) Submission Details - K935012

510(k) Number K935012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date March 07, 1994
Days to Decision 138 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 122d · This submission: 138d
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 522
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K935012.
FOUNDATION ALL POLY CUP
K934169 · Encore Orthopedics, Inc. · May 1994
RMHS POROUS DISTAL SLEEVE
K932574 · Smith & Nephew Richards, Inc. · Mar 1994
OSTEONICS OMNIFIT FORGED HIP STEM SERIES
K933561 · Osteonics Corp. · Mar 1994
OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
K930187 · Osteonics Corp. · Mar 1994
PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE
K933875 · Howmedica Corp. · Mar 1994
PRECISION OSTEOFLEX FEMORAL COMPONENT
K903630 · Howmedica Corp. · Feb 1994