Cleared Traditional

K915528 - BHR BIPOLAR FEMORAL HEAD COMPONENT

K915528 is an FDA 510(k) clearance for BHR BIPOLAR FEMORAL HEAD COMPONENT, manufactured by Implantology Corp.. The device is a Class 2 Orthopedic device with product code LZY cleared through the Traditional 510(k) pathway after a 567-day FDA review.

K915528 · Implantology Corp. · Orthopedic device
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Jun 1993
Decision
567d
Days
Class 2
Risk

K915528 is an FDA 510(k) clearance for the BHR BIPOLAR FEMORAL HEAD COMPONENT. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal Ball (product code LZY), Class II - Special Controls.

Submitted by Implantology Corp. (Pine Brook, US). The FDA issued a Cleared decision on June 29, 1993 after a review of 567 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Implantology Corp. devices

FDA 510(k) Submission Details - K915528

510(k) Number K915528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1991
Decision Date June 29, 1993
Days to Decision 567 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
445d slower than avg
Panel avg: 122d · This submission: 567d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZY Device Classification - Class 2, Special Controls

Product Code LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball

All 7
Devices cleared under the same product code (LZY) and FDA review panel - the closest regulatory comparables to K915528.
TANDEM Hip System
K231448 · Smith & Nephew, Inc. · Jul 2023
ENDO HEAD
K111145 · Medacta International · Aug 2011
PRE-POWDERED NITRILE EXAMINATION GLOVES
K974442 · P.T. Latexindo Tobaperkasa · Jan 1998
IONGUARD TITANIUM MODULAR HEADS
K915548 · Biomet, Inc. · Mar 1992
MODULAR CATHCART FRACTURE SYSTEM
K903084 · Depuy, Inc. · Oct 1990
UNI-POLAR HEAD
K896580 · Richards Medical Co., Inc. · Feb 1990