Cleared Traditional

SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP (K874093) - FDA 510(k) Clearance

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

K874093 · Protek, Inc. · Orthopedic device
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Jan 1988
Decision
111d
Days
Class 2
Risk

K874093 is an FDA 510(k) clearance for the SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP. 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 January 27, 1988 after a review of 111 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 Protek, Inc. devices

Submission Details

510(k) Number K874093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1987
Decision Date January 27, 1988
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
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 K874093.
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM
K882812 · Osteonics Corp. · Aug 1988
LCS FEMORAL HIP PROSTHESIS
K880269 · Depuy, Inc. · May 1988
TITANIUM FEMORAL HIP
K881128 · Depuy, Inc. · Mar 1988
ANATOMIC TOTAL HIP
K874229 · Zimmer, Inc. · Nov 1987
POROUS COATED ACETABULAR CUP
K873585 · Johnson & Johnson Professionals, Inc. · Oct 1987
HPS II CALCAR FEMORAL PROSTHESIS
K871857 · Depuy, Inc. · Jun 1987