Cleared Traditional

MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY (K861988) - FDA 510(k) Clearance

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

K861988 · Protek, Inc. · Orthopedic device
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Feb 1987
Decision
278d
Days
Class 2
Risk

K861988 is an FDA 510(k) clearance for the MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY. 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 February 11, 1987 after a review of 278 days - an extended review 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: 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 Protek, Inc. devices

Submission Details

510(k) Number K861988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1986
Decision Date February 11, 1987
Days to Decision 278 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 122d · This submission: 278d
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 K861988.
STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP
K870699 · Depuy, Inc. · May 1987
MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS
K870216 · Osteonics Corp. · Mar 1987
THREADED ACETABULAR COMPONENT
K870445 · Johnson & Johnson Professionals, Inc. · Mar 1987
AML II TITANIUM ACETABULUM PROSTHESIS
K861979 · Depuy, Inc. · Jan 1987
PROFILE HIP ACETABULUM PROSTHESIS
K863184 · Depuy, Inc. · Jan 1987
UNIVERSAL ACETABULAR COMPONENT
K861433 · Biomet, Inc. · Oct 1986