Cleared Traditional

K990830 - MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS

K990830 is an FDA 510(k) clearance for MALLORY/HEAD CALCAR REPLACEMENT WITH IN..., manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K990830 · Biomet, Inc. · Orthopedic device
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Apr 2000
Decision
396d
Days
Class 2
Risk

K990830 is an FDA 510(k) clearance for the MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLL.... Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 11, 2000 after a review of 396 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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. Elevated predicate reliance profile. 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K990830

510(k) Number K990830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1999
Decision Date April 11, 2000
Days to Decision 396 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
274d slower than avg
Panel avg: 122d · This submission: 396d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 544
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K990830.
PINNACLE ACETABULAR SYSTEM
K001534 · DePuy Orthopaedics, Inc. · Jun 2000
REACH FEMORAL COMPONENT
K000760 · Biomet, Inc. · May 2000
KEYSTONE HIP
K000521 · Encore Orthopedics, Inc. · May 2000
HEMISPHERE MODULAR CUP SYSTEM
K000321 · Ortho Development Corp. · Apr 2000
BICON-PLUS ACETABULAR COMPONENTS
K992154 · Plus Orthopedics · Apr 2000
ESKA MODULAR HIP SYSTEM
K993027 · Specs USA, Inc. · Apr 2000