Cleared Traditional

K873632 - HI-NEK TOTAL HIP

K873632 is an FDA 510(k) clearance for HI-NEK TOTAL HIP, manufactured by Orthopedic Systems, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K873632 · Orthopedic Systems, Inc. · Orthopedic device
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Dec 1987
Decision
90d
Days
Class 2
Risk

K873632 is an FDA 510(k) clearance for the HI-NEK TOTAL HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on December 7, 1987 after a review of 90 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 Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K873632

510(k) Number K873632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1987
Decision Date December 07, 1987
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K873632.
MOORE HIP PROSTHESIS SOLID STEM
K874599 · Orthopedic Systems, Inc. · Jan 1988
MOORE HIP PROSTHESIS FENESTRATED STEM
K874616 · Orthopedic Systems, Inc. · Jan 1988
FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM
K873626 · Orthopedic Systems, Inc. · Dec 1987
WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS
K873857 · Dow Corning Wright · Dec 1987
ANATOMIC TOTAL HIP
K874229 · Zimmer, Inc. · Nov 1987
POROUS COATED ACETABULAR CUP
K873585 · Johnson & Johnson Professionals, Inc. · Oct 1987