Cleared Traditional

K853768 - MULLER SELF LOCKING TOTAL HIP

K853768 is an FDA 510(k) clearance for MULLER SELF LOCKING TOTAL HIP, manufactured by Protek, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K853768 · Protek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
71d
Days
Class 2
Risk

K853768 is an FDA 510(k) clearance for the MULLER SELF LOCKING TOTAL HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 19, 1985 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Protek, Inc. devices

FDA 510(k) Submission Details - K853768

510(k) Number K853768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date November 19, 1985
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 K853768.
HPS II SMOOTH STEM
K860701 · Depuy, Inc. · Mar 1986
ARTHOPOR-ACETABULAR COMPONENT
K844050 · Joint Medical Products Corp. · Dec 1985
P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM
K853886 · Howmedica Corp. · Nov 1985
CONICAL COLLAR HIP PROSTHESIS
K854046 · Kirschner Medical Corp. · Nov 1985
COLLAR LESS AML HIP
K853408 · Depuy, Inc. · Nov 1985
GT HIP PROSTHESIS FEMORAL COMPONENT
K853169 · Intermedics Orthopedics · Oct 1985