Cleared Traditional

K861988 - MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY

K861988 is an FDA 510(k) clearance for MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY, 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 278-day FDA review.

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

FDA 510(k) Submission Details - K861988

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
Combination Product No
PCCP Authorized No
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.

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 K861988.
OPTI-FIX ACETABULAR COMPONENT
K864857 · Richards Medical Co., Inc. · Mar 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